Manufacturing Engineer
Engineer Job In Villalba, PR
Develop Validations Documents (Master Validation Plans/Reports, Test Method Validations, IQ, OQ and/or PQ, CSV related documents), Execute Validations in assigned Manufacturing Areas, and generate Reports. Document and execute IQ for label printing, Implement Manufacturing processes changes through CCB. Able to implement EU MDR requirements (such as PIC card implementation, Manufacturing/PFMEA, FAI, manuals and new pins implementation
/ FW Configuration changes and other required activity per EU MDR requirements). Develop and/or revise PPM or DOTM as required. Support during submission documents review as applicable.
Responsibilities may include the following and other duties may be assigned. Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
1. Some experience in process validation , test method validation, CSV, handling of manufacturing process changes implementation (at packaging and/or manufacturing process flow).
2. Responsible, able to learn fast and adapts to continues changes in project schedule priorities as required. Able to coordinate and manage activities with multiple functions, able to apply problem solving techniques (critical thinking skills) to move roadblock without impact project schedule activities
3. Teamwork oriented, good communication skills, results oriented
Education Required: Bachelor degree in engineering
Years' Experience Required: Minimum of two years preferred with some experience, intermediate position. Willing to evaluate good potential candidates at entry level
Engineering Compliance Administrator
Engineer Job In Manat, PR
Kelly Engineering is seeking **_Engineering Compliance Administrator _** for a **12 month contract** position at a **Global Pharmaceutical** client in **Manati, Puerto Rico.** If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
**Salary: $30.00 per/hour**
**Overview**
This client is Global Biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
_In this role you'll be responsible for managing all engineering & maintenance quality assurance activities for products manufactured, packaged or tested at local operations, deviations management and change control._
This role will give you an opportunity to transform patients' lives through science by contribute with a global leading biopharma company powered by talented individuals who drive scientific innovation _._
**Schedule:** Office hours, but with the flexibility that we are working with projects and the hours can be extended.
**Responsibilities:**
+ Promotes and ensures compliance with applicable site requirements, KPIs, cGMP regulations, and other applicable regulations.
+ Demonstrates proficiency and thorough knowledge of statistical techniques, SPC, six sigma concepts and tools, and area policies and procedures.
+ Maintains a current and thorough working knowledge of cGMP requirements for pharmaceutical manufacturing, packaging, laboratory and validation activities.
+ Lead the engineering and maintenance deviations, compliance, change controls, among others. Ensure that the engineering and maintenance deviations, compliances, change controls, among others are completed on time.
+ Develop root cause analysis as part of the investigation process.
+ Support product transfers and/or launches as per business requirements
+ Ensure KPIs compliance
**Qualifications:**
+ Associate or Bachelor Degree with five (5) years experience in pharmaceutical industry in a similar or related role.
+ Technical Skills: Maximo application user or SAP application user.
+ Fully bilingual (Spanish/English) communication skills, both written and verbal.
**What happens next:**
Once you apply, you'll proceed to next steps if your skills and experience look like a good fit. But don't worry - even if this position doesn't work out, you're still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (********************************************************************* for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly Engineering?
Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career.
About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center.
Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Project Engineer
Engineer Job In Arecibo, PR
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Project Engineer (This is a Pipeline requisition for future Project Engineer Opportunity at Abbott)
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.
The Opportunity
This position works out of our Arecibo location in the CRM division.
As the Project Engineer, you will Manage all aspects of an engineering project, from start to finish, so that it is completed on time and within budget.
What You'll Do
* Design, communicate, and implement an operational plan for completing the project.
* Monitor progress and performance against the project plan.
* Take action to resolve operational problems and minimize delays.
* Identify, develop, and gather the resources to complete the project.
* This may include preparing engineering designs and work specifications, developing project schedules, budgets and forecasts, and selecting materials, equipment, project staff, and external contractors.
* Liaise with other operational areas in the organization (e.g., engineering, drafting, technical) to secure specialized resources and contributions for the project.
* Select and manage the activities of contractors to ensure they are integrated into the project and the organization receives satisfactory standards of service.
* Conduct meetings and prepare reports to communicate the status of the project.
* Set priorities, allocate tasks, and coordinate project staff to meet project targets and milestones.
Required Qualifications
* B.S. in Engineering
* Minimum of three (3) years of experience.
Preferred Qualifications
* Previous experience in regulated environment, preferable medical devices.
Apply Now
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at *************** on Facebook at *********************** and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is $53,300.00 - $106,700.00. In specific locations, the pay range may vary from the range posted.
Manufacturing Engineer II
Engineer Job In Villalba, PR
What are the top 3 things you are looking for in a candidates experience: Equipment installation, set up, and installation qualification. Technical writing of reports and procedures. Manufacturing process validation. Education Required: BS in Engineering
Years' Experience Required: 2 years relevant experience minimum
JOB DESCRIPTION
Responsibilities may include the following and other duties may be assigned. Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
*Weil Group is proud to be an Equal Employment Opportunity Employer.*
Manufacturing Engineer II - 048
Engineer Job In Villalba, PR
For engineering services in the Manufacturing area.
WHAT MAKES YOU A FIT:
The Technical Part:
Bachelor's Degree in Engineering and two (2) year of exposure within the Medical Devices Industry.
Bilingual: Spanish and English
Soft Skills: Excellent teamwork skills
Shift: Administrative and according to business needs.
Experience in:
Equipment installation, setup, and Installation Qualification.
Technical Writing of reports and procedures.
Manufacturing Process Validations.
The Personality Part:
Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece?
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
Designs manufacturing processes, procedures, and production layouts for assemblies, equipment installation, machining, and material handling.
Design arrangement of machines within plant facilities to ensure the most efficient and productive layout.
Designs the sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
Adapts machine or equipment design to factory and production conditions.
May incorporate inspection and test requirements into the production plan.
Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action.
Develops manufacturing processes that apply to statistical process control, and may develop those techniques.
Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
Ensures processes and procedures comply with regulations.
WHO WE ARE:
We are a Service Provider company different from the rest. We pride ourselves on how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented, and focused on our resources' well-being, while providing our Pharmaceutical, Medical Devic,e and Manufacturing industry clients with top-notch quality talent. We're FITS!
Are you the Next Piece?
Manufacturing Engineer II
Engineer Job In Aasco, PR
Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
**ESSENTIAL DUTIES AND RESPONSIBILITIES**
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
1.Development and update of manufacturing process flow chart.
2.Maintenance and update of manufacturing documentation such as: BOM/production routers, procedures, drawings, specifications, etc.
3.Maintenance and upgrade existing products/processes.
4.Develops and/or executes validations of revised/new raw materials, products, processes and/or equipment following Integra procedures.
5.Develops, coordinates, and implements the change controls related to each manufacturing engineering project. Evaluates and assures completeness of change control requirements for projects under responsibility.
6.Develops the required documentation, procedures, drawings, protocols, engineering change notices, technical reports and other information as required by the company.
7.Submits requisitions of components, materials, equipment, machinery, services, tooling and fixtures to supervisor for approval as part of engineering projects.
8.Oversee installations to ensure machines and equipment are installed and functioning according to specifications. Troubleshoots equipment/processes that do not perform as intended.
9.Provides engineering technical support to manufacturing areas.
10.Develops and implements scrap reduction initiatives.
11.Develops and implements capacity increase projects.
12.Evaluates and update manufacturing time standards.
13.Develops and implements cost improvement projects.
14.Analyzes layout of equipment, workflow, assembly methods, and work force utilization standards to maximize the manufacturing processes efficiency.
15.Evaluates and implements product labeling and printed materials changes.
16.Evaluates and implements raw material/components changes.
17.Evaluates and/or implements change controls and engineering change orders (ECO, DCO, MCO).
18.Evaluates, investigates and documents non-conformances incidents. Provides support on the assessment and disposition of non-conforming material.
19.Completes assigned Non-Conformance and CAPA investigations and prepare investigation reports.
20.Implementation of corrective and preventive actions for process related concerns.
21.Supports in the investigation and resolution of supplier quality issues.
22.Supports the introduction of new businesses and products/processes.
23.Participates in the development of the new processes, process transfers and continuous improvement, and issue resolution.
24.Supports the transfer of products/processes to outside facilities.
25.Development of process controls for new and existing equipment and/or processes.
26.Reviews and approves validations and completion reports for new and existing products, processes and equipment.
27.Develops and implements metrics to monitor the performance of manufacturing areas.
28.Develops and implements Six Sigma/Lean projects and quality improvement plans. Identify and implement opportunities for continuous improvement.
29.Develops and conducts product/process training programs and demonstrates skills to trainees, using hand tools, precision measuring instruments, following schematics, drawings, procedures, and manufacturer's specifications.
30.Prepares information for Quality Management Reviews and Operational Reviews such as: trending charts, Pareto analysis, etc.
31.Participates in the compilation and review of technical documentation for both domestic and international regulatory submissions.
32.Participates in external audits such as: FDA, Notified Body (BSI) and Corporate, among others.
33.Will partner with Manufacturing and Quality departments to ensure that the development, manufacture and distribution of medical products is in compliance with corporate policies and regulatory requirements (International Organization for Standardization (ISO)/ European Norm (EN)/ European Medical Device Directive (MDD)/ Canadian Medical Device Regulation (CMDR) standards/ sections, Quality System Regulation (21CFR 820, 21CFR 11 and other associated FDA regulations), and other applicable regulatory agencies).
34.Performs other related duties as necessary.
DESIRED MINIMUM QUALIFICATIONS - Education and Experience
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
*BS in Engineering, preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical.
*Master's degree is a plus.
*PE License strongly desired.
*Lean/Six Sigma Green or Black Belt Certification is a plus.
*Minimum of 3 - 5 years of experience in the medical device and/or pharmaceutical manufacturing environment; with at least three (3) years in a manufacturing process or quality engineering position and preferably with exposure to Design Control and Product/Process Transfer.
*Knowledge in Collagen and Silicone technologies and materials as well as lyophilization and dispersion preparation is highly desirable.
*Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements.
*Knowledge in Organizational Excellence and Lean/Six Sigma.
*Strong Project Management skills.
*Effective knowledge in Microsoft Project software.
*Knowledge of cost control, and development of guidelines, training, and maintenance programs.
*Ability to lead teams through complex projects and provide departmental technical leadership.
*Must have excellent communication skills and a strong track record of working cross-functionally.
*Must have demonstrated ability to think strategically.
*Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others.
*Experience in Design Control procedures and regulation is desirable.
*Teamwork oriented and self-starter.
*Fully bilingual (English and Spanish).
*Availability to work extended hours in the day and weekends as required.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law (************************************ | EOE including Disability/Protected Veterans (********************************************************************
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (************************************************** . If you have difficulty using our online system due to a disability and need an accommodation, please email us at *********************** or call us at ************.
Integra - Employer Branding from Integra LifeSciences on Vimeo (*****************************************
Manufacturing Engineer
Engineer Job In Aasco, PR
PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning and Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.
PharmEng Technology aims to create a conducive work environment that fosters empowerment, passion, and perseverance while serving our clients to achieve their unique business goals.
Utilizes advanced skills to perform complex preventive maintenance and corrective repair of buildings, industrial systems, vehicles, equipment, and grounds. Working under limited supervision monitors building system operations and performance. Utilizes several trade skills such as carpentry, plumbing, electrical, painting, roofing, heating, and cooling.
We are looking for a Manufacturing Engineer to help us implement manufacturing processes that result in high-quality products.
You need to have a good knowledge of tool design and fabrication methods. Other necessary manufacturing engineer skills include project management ability, commitment to quality, and familiarity with safety and environmental standards. If you're also inventive and meticulous, we'd like to meet you.
Ultimately, you'll be the one to ensure our production lines work efficiently and effectively to satisfy our customers.
Responsibilities
Evaluate manufacturing processes based on quality criteria, such as efficiency and speed.
Study production and machine requirements.
Develop and test effective automated and manual systems.
Design and install equipment.
Organize and manage manufacturing workflows and resources.
Integrate disparate systems (e.g. equipment handling, transport).
Optimize facility layouts, production lines, machine operations, and network performance.
Resolve issues and delays in production.
Find ways to reduce costs and maximize quality.
Train staff in new and existing processes.
Collaborate with other engineers, contractors, and suppliers.
Upgrade systems and processes with new technology.
Requirements and skills
Previous experience as a manufacturing engineer
Knowledge of manufacturing processes, fabrication methods, and tool design.
Familiarity with manufacturing equipment and quality assurance techniques.
Commitment to health and safety standards and environmental regulations.
Experience in mechanical engineering
Working experience with product lifecycle management (PLM), finite element analysis (FEA) and computational fluid dynamics (CFD)
Hands-on experience with computer-aided engineering (CAM) and computer-aided manufacturing (CAE)
Well-versed in relevant software (e.g. CAD, MS Office),
Project management skills.
Problem-solving ability.
Teamwork skills.
Degree in Engineering
Mechanical Design Engineer II
Engineer Job In Aguadilla, PR
As a Mechanical Design Engineer II here at Honeywell, you will help manage the prioritization of tasks related to design changes needed to keep parts flowing through the factory. This role will be focused on understanding what are the engineering resources needed to complete the requested engineering design changes and execute the change to enable our Integrated Supply Chain (ISC) to manufacture our products.
You will report directly to our Engineering Manager, and you'll work out of our Aguadilla, Puerto Rico location.
As the project manager/engineer for Class 2 engineering design changes (CL2.) The engineer must manage the requested changes in the most effective way. The selected candidate will be providing support to different sites as prioritized in relation to our supply chain requirements.
Key Responsibilities:
+ Work on open engineering actions assigned to the Global Operations Engineering Services (GPES) team, which may include Honeywell Service Requests (HSR), Supplier Engineering Request (SER), Work Authorization Request Process (WARP), among others
+ Use available Quality Notifications and supplier deviations data to drive recovery or backlog reduction action plans
+ Be the focal point between ISC Engineering, Supplier Development Engineering (SDE), Procurement & GPES
+ Execute action plans to improve internal / external Engineering Change (EC / SER) backlog burndown
+ Partner with the Configuration Management teams (CMADS) to expedite Internal & External Customer Reviews
Travel between 10 and 20% can be expected, domestic and international.
BENEFITS OF WORKING FOR HONEYWELL
In addition to a performance-driven salary, cutting-edge work, and developing solutions side-by-side with dedicated experts in their fields, Honeywell employees are eligible for a comprehensive benefits package. This package includes employer-subsidized Medical, Dental, Vision, and Life Insurance; Short-Term and Long-Term Disability; 401(k) match, Flexible Spending Accounts, Health Savings Accounts, EAP, and Educational Assistance; Parental Leave, Paid Time Off (for vacation, personal business, sick time, and parental leave), and Paid Holidays.
The application period for the job is estimated to be 40 days from the job posting date; however, this may be shortened or extended depending on business needs and the availability of qualified candidates.
U.S. PERSON REQUIREMENTS
Due to compliance with U.S. export control laws and regulations, candidate must be a U.S. Person, which is defined as, a U.S. citizen, a U.S. permanent resident, or have protected status in the U.S. under asylum or refugee status.
MUST HAVE:
+ Bachelor's degree from an accredited institution in technical disciplines such as the sciences, technology, engineering or mathematics.
+ 2+ years managing engineering projects, can include:
+ New product introduction
+ Experience working with vendors (procure parts or equipment, vendor certifications, etc.)
+ Experience on capital projects
+ Leading cross-functional project
+ Continuous improvement/cost reduction experience
+ Ability to read, write and speak English
WE VALUE:
+ Bachelor's degree in mechanical engineering preferred, Industrial, or Electrical Engineering may be considered
+ Aerospace experience
+ Excellent verbal and written communication and presentation skills
+ PMP Certification
+ Willingness to learn new technologies
+ Individuals who are self-motivated and able to work with little supervision, who consistently take the initiative to get things done, do things before being asked by others or forced by events.
+ Possess a positive attitude and professional image with impeccable business ethics
+ Experience with SAP & JIRA
+ Ability to understand and establish priorities in a complex and demanding environment
+ Work in a matrix environment with a focus on building relationships and driving improvements over multiple locations
+ An engineer with project management skills who is well organized, detail oriented and self-motivated
+ Strong drawing and specifications interpretations skills
+ Six Sigma Green Belt certification and technical proficiency in the use of Excel and other Microsoft Office tools
ABOUT HONEYWELL
Honeywell International Inc. (Nasdaq: HON) invents and commercializes technologies that address some of the world's most critical demands around energy, safety, security, air travel, productivity, and global urbanization. We are a cutting-edge software-industrial company dedicated to introducing state-of-the-art technology solutions to improve efficiency, productivity, sustainability, and safety in high-growth businesses in broad-based, attractive industrial end markets. Our products and solutions enable a safer, more comfortable, and more productive world, enhancing the quality of life of people around the globe. Learn more about Honeywell: click here (********************************
THE BUSINESS UNIT
Honeywell Aerospace Technologies (AT) products and services are found on virtually every commercial, defense, and space aircraft in the world. We build aircraft engines, cockpit and cabin electronics, wireless engage systems, mechanical components, and more, and engage many of them via our high-speed Wi-Fi offerings. Our solutions create healthier air travel, more fuel-efficient and better-maintained aircraft, more direct and on-time flight arrivals, safer skies and airports, and more comfortable flights, along with several innovations and services that reflect exciting and emerging new transportation methods such as self-reliant and supersonic flight. Revenues in 2023 for Honeywell Aerospace Technology were $14B and there are approximately 21,000 employees globally. To learn more, please visit click here (*********************************
Honeywell is an equal opportunity employer. Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, religion, or veteran status.
Mechanical Design Engineer II (Hybrid-Puerto Rico)
Engineer Job In Aguadilla, PR
**Country:** United States of America ** Hybrid Collins Aerospace has an exciting opportunity for a **Mechanical Design Engineer** to innovate, design, develop, and implement technologies, components, sub-systems, machines, tools, and systems, and ensure compliance to specifications, requirements, and customer guarantees across applicable operating conditions using computer design and engineering systems.
This position will sit at our **Aguadilla, PR** location. You must be residing in Puerto Rico at the time of starting employment. Relocation is not offered.
This role is categorized as **hybrid** , with 3 days onsite and 2 days remote following the schedule assigned by the Manager.
**What YOU will do:**
+ Conduct design activities of Landing Gear and Systems components working within an integrated product development team and coordinating with divisional engineering to ensure product excellence and integrity is achieved.
+ Liaise with customer/suppliers for all design related issues.
+ Generate design documentation such as tolerance stack-ups, developmental and kinematic assemblies, interface agreements and proximity sensing analysis.
+ Generates layouts and conduct trade studies to determine optimal design solutions.
+ Generate detailed part and assembly definition drawings and models/FTA using CATIA V5 and other relevant design tools.
+ Create associated parts lists supporting part definition.
+ Investigate design related issues and develop effective solutions.
+ Develop Landing Systems mechanisms, from customer specifications, considering regulatory requirements and Collins Engineering methodologies.
+ Present designs proposals at internal reviews to ensure the design meets requirements and expectations.
+ Generate test requirements and support the test lab for design related tests.
+ Performs Engineering investigations into failures and participates in Root Cause and Corrective Action.
+ Generate CR/CO through Team Center
+ Travel up to 10% domestically and internationally when circumstances permit.
**What YOU will learn:**
+ You will learn about our growing engineering team in Puerto Rico; What we do? Who we support? How we work?
+ You will learn the technologies of today and tomorrow which we count on to maintain world leadership in the aerospace industry.
+ You will learn why people enjoy and feel fulfilled by working in our industry.
**Qualifications you must have:**
+ Typically requires a degree in Science, Technology, Engineering or Mathematics (STEM) and minimum 2 years of prior relevant experience or an Advanced Degree in a related field or in absence of a degree, 6 years of relevant experience.
+ Demonstrated professional experience communicating in English (verbal and written).
+ U.S. citizenship is required, as only U.S. citizens are authorized to access information under this program/contract.
**Qualifications We Prefer:**
+ Degree in Mechanical Engineering or Civil Engineering
+ Pro-efficient in Siemens NX, Visio, PTC CREO Parametric is a plus, Solidworks, CATIA.
+ Desirable experience in CNC Manufacturing, Mechanical Design.
+ Experience interacting with Mechanical/Electrical Computer Aided Design Resources (MCAD and ECAD).
+ Experience interacting with configuration management (CM).
+ Knowledge and Experience working Geometric Dimensioning and Tolerancing (GD&T), Tolerance Stack up Calculation, Weight Analysis, etc.
+ Proficient in NX NASTRAN, ANSYS tools and/or ABAQUS FEA software is a plus.
**What We Offer**
Some of our competitive benefits package includes:
+ Medical, dental, and vision insurance
+ Three weeks of vacation for newly hired employees
+ Generous 401(k) plan that includes employer matching funds
+ Participation in the Employee Scholar Program (ESP)
+ Life insurance and disability coverage
+ Employee Assistance Plan, including up to 8 free counseling sessions.
+ And more!
**Learn More & Apply Now!**
Collins Aerospace, an RTX business, is a leader in technologically advanced and intelligent solutions for the global aerospace and defense industry. Collins Aerospace has the capabilities, comprehensive portfolio, and expertise to solve customers' toughest challenges and to meet the demands of a rapidly evolving global market.
In January 2021, Collins Aerospace expanded a new Global Engineering Center (GEC) facility in Puerto Rico, with plans to continuously hire over the next 5 years, at our Aguadilla site.
Join our growing engineering team in Puerto Rico, where you will provide critical support to all Collins SBUs, working on exciting programs and projects ranging from the development of the next generation of advanced concept ejection seats to the latest technologies for the U.S. warfighter.
**WE ARE REDEFINING AEROSPACE.**
* Please consider the following role type definition as you apply for this role.
**Hybrid:** Employees who are working in Hybrid roles will work regularly both onsite and offsite. Ratio of time working onsite will be determined in partnership with your leader.
At Collins, the paths we pave together lead to limitless possibility. And the bonds we form - with our customers and with each other -- propel us all higher, again and again.
Apply now and be part of the team that's redefining aerospace, every day.
_RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans' Readjustment Assistance Act._
**Privacy Policy and Terms:**
Click on this link (******************************************************** to read the Policy and Terms
Raytheon Technologies is An Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age or any other federally protected class.
Project Engineer
Engineer Job In Aguadilla, PR
Nova Group Inc., a Quanta Services company, is an industry leading general engineering construction company with 40 plus years of experience worldwide. Nova specializes in hydrant fueling, waterfront, electrical and utility military construction projects for the Department of Defense (NAVFAC, ACOE). Nova exceeds customer expectations through innovative construction, safety, quality and outstanding customer service. Headquartered in Napa, CA, with regional offices in Port Orchard, WA, Japan and project locations stretching across the US, as well as internationally, the opportunities are endless with Nova! Nova offers employees competitive health benefits, matching 401K contributions, career advancement opportunities, and endless training opportunities. Individuals who pride themselves on having a strong work ethic, commitment to their integrity, interest in giving back to local communities, and who are willing to relocate for career advancement opportunities should not hesitate to apply!
Summary:
Assigned to project in Puerto Rico and performing tasks such as project management, technical review, input and planning, budget control, production, quality control and scheduling under the guidance of the field operations team.
What you will be doing:
* Meets with team regularly to review production schedule and confirm all materials, equipment and resources are readily available for production to continue on schedule and within budget.
* Reviews shop drawings, design specifications, material requirements and project data through the duration of the project to ensure quality and contract specification compliance.
* Provides technical input for project work plan and scheduling. Identifying risk elements of production, materials, equipment or process that could negatively impact the budget or schedule.
* Evaluates daily production, schedule and budget projections to accurately track project performance. Documents daily activities in Company approved methods and technologies.
* Updates project schedule weekly for owner and management reporting. Attends weekly owner meetings; presents project production status as needed.
* Perform additional assignments per management's direction.
* Prepares and manages a three-week work plan. Notifies engineering and project management of any significant schedule changes and develops solutions to mitigate delays and cost.
* Initiates and manages all Requests for Information (RFIs), as needed by project.
* Remits accurate project quantities using assigned project cost coding to ensure project financials are accurately reported. Manages invoicing with Company accounting team regarding materials, equipment and subcontractor needs.
* Supports the team with quality assurance as needed. Reviews certificates and permits needed to perform work. Participates in all worksite tours with leadership or external parties.
* Reviews required Job Hazard Analysis (JHAs) to ensure a safe and compliance work environment for all construction personnel. Participates in all weekly safety meetings with field team and project leadership; presents field analysis as needed.
* Assists the development of design drawings and provides technical input, as needed.
* Coordinates subcontractor work methods, schedule and crews as needed.
* Reconciles job close-out checklist with owner representative and field crews at the end of the project.
* Maintains knowledge of Company values and strategic plan.
What we are looking for:
* Bachelor's degree in engineering or construction management required.
* 3+ years construction engineering experience required.
* Electrical construction experience including high voltage preferred.
* Able to identify budget and project costs and recommend options to mitigate project delays.
* Possess verbal, written and presentation skills.
* Knowledge of design build and other alternative delivery methods.
* Knowledge of financial reporting methods, quantity tracking methods and cost coding.
* Knowledge of construction scheduling and production time management preferred.
* Ability to assume responsibility, interface and communicate effectively with others.
* Proficient in Microsoft Suite, Bluebeam, and AutoCAD.
Physical Requirements:
* Prolonged periods of sitting at a desk and working on a computer in an office environment.
* Must be able to access and navigate all areas of construction site in all types of weather.
* Prolonged periods of standing and working outside.
* Must be able to lift up to 40 pounds at times.
Position Type and Expected Hours of Work:
This is a full-time exempt from overtime position. Days and hours of work will depend on production schedule.
Salary Range:
$40,000 - $65,000
We are committed to helping individuals with disabilities participate in the workforce and ensuring equal opportunity to apply and compete for jobs. If you need assistance or have a request for an accommodation of a qualified disability to apply for a job posting, please email or write us at the address below and we'll be happy to help. All others interested in applying for a job posting should do so through our career site.Nova Group, Inc.
c/o Human Resources
185 Devlin Rd
Napa, CA 94558
Equal Opportunity Employer, including Women, Disabled, and Veterans.
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View Company Information
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Manufacturing Engineer (Temporary position)
Engineer Job In Barceloneta, PR
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok (******************************* .
Job Description
The Manufacturing Engineer is responsible of providing technical assistance to the manufacturing areas related to the manufacturing process and equipment. These areas are highly dependent on technique, detailed procedures, equipment and controls. The position requires dealing with difficult technical problems in a highly technical and regulated environment. This position requires developing and implementing changes that will improve equipment performance and consequently product quality in the manufacturing areas and reduce manufacturing costs, maintaining a constant product turnover. Develop and modify procedures as needed to support the manufacturing operation. Participate in process, equipment, and facilities validation efforts and project implementations. Investigate process exceptions or equipment malfunction incidents affecting the process. Maintain the manufacturing area equipment in compliance with the calibration and maintenance programs.
Responsibilities
+ Comply with Abbvie policies and procedures, Engineering Standards and Specifications, and regulatory agency regulations and requirements. Provide technical assistance to the manufacturing areas.
+ Assist in the troubleshooting of manufacturing equipment and processes. Investigate process and equipment exceptions and follow up CAPA implementation. Revise SOP's and PCR and submit Change Requests (CR) for approval.
+ Develop and implement changes that will improve equipment performance and consequently product quality in the manufacturing areas and reduce manufacturing costs. Evaluate and implement new equipment technology.
+ Initiate capital project ideas dealing with safety, quality improvement, capacity increase, and/or cost reduction. Establish requirements and assist in the implementation of changes to the Process Control System.
+ Participate in the development and execution of validation protocols. Participate in manufacturing personnel training.
+ Give direct support to the manufacturing process and trouble shootings. Provide assistance to operations in the control, management and disposal of household wastes, biomedical and hazardous to their respective area as applicable, ensuring compliance with federal and local regulations and policies following plant, division and corporate procedures.
+ Provide support to supervisors in the batch record audit process and discrepancies closures.
+ Provide assistance during Regulatory Agency Audits.
Significant work activities
+ Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
+ Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
+ Continuous walking for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
+ Work in a clean room environment
Qualifications
Qualifications
+ Bachelors Degree in Engineering is required (Chemical or Mechanical preferred)
+ Requires minimum two (2) years of total combined experience in Process / Equipment or Manufacturing Engineering of a Pharmaceutical, Biotechnology, API or Medical Devices industry.
+ Previous experience experience in the manufacturing environment of Pharmaceutical, Biotechnology, API or Medical Devices industry.
+ Knowledge in manufacturing equipment troubleshooting.
+ Previous experience with Control Systems; DeltaV and MES preferred.
+ Knowledge of quality regulations and standards affecting chemical, biological or medical devices. knowledge of corporate, local, state, and OSHA regulations.
+ Excellent verbal and written communication skills in both, English and Spanish.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
+ The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
+ We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
+ This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
US & Puerto Rico only - to learn more, visit *************************************************************************
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
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Head of Facilities, EHS and Utilities Engineering
Engineer Job In Yauco, PR
Responsible for the effective management and operation of all the Facilities, Utilities and EHS systems and programs. Play an active role in the development and completion of projects, meet and report back to upper management, plan and monitor work schedules and cash flows, and work with multiple and diverse teams. Align engineering activities and projects with company goals and objectives, providing guidance and support and maintaining positive relationships with both internal and external stakeholders. Assess the facility's resource requirements, designing, and optimizing the facility's layout and critical operational systems, and overseeing the performance of the EHS program and the maintenance of the infrastructure and all related equipment's.
Grow with us- Your Responsibilities & Tasks:
* Directs and coordinates all the facilities engineering departmental operations.
* Implements best practice engineering methods and technologies.
* Designs strategies for future development projects based on the company's overall objectives.
* Supervises department managers and foresees that the goals and objectives of each function are accomplished in a timely and accurate manner.
* Finds and implementing ways to improve cost-efficiency.
* Monitor reliability and performance of all systems and programs to suggest improvements.
* Prepares and manage the facilities engineering department's budget including the capital plan.
* Analyze project costs and time schedule to guarantee successful implementation.
* Ensures compliance with standards, building codes, and environmental, health and safety regulations.
* Ensures EHS programs are effectively implemented and communicates any deficiencies for corrective actions.
* Coordinates with external stakeholders for new integrations and tools.
* Prepares reports and compliance documentation.
What will convince us- Qualification & Skills:
* Demonstrated leadership skills with strategic mindset.
* Management and administrative skills (the ability to analyze, delegate, and organize) are required.
* Impeccable verbal and written communication skills in English and Spanish.
* Excellent project management skills.
* Analyzes and interpret general business periodicals, professionals' journals, technical procedures and government regulations.
Education/Experience/Skills:
* Bachelor's degree in electrical, Mechanical, Civil or Chemical Engineering is preferred.
* Minimum of 10 years of experience in the medical device and/or pharmaceutical industry.
* 8+ years' experience in a technical management position.
* Good knowledge of the Utilities Equipment (Chillers, HVAC, Water Systems, etc.
* Good knowledge of the EHS federal and local regulations.
* Vast experience with audit management.
What We Offer:
* Paid vacation and sick leave
* 14 paid holidays annually
* Impressive campus: Located on 219,000 square meters, our campus is home for more than 1,000 employees.
* We offer an open-office concept, a spacious outdoor area, conference areas and a development center.
* Medical, Dental and Vision insurance along with Company Retirement Plan
* On-site cafeteria and coffee shop
* On-site occupational health offices including Laboratory Services & Doctors
Driving our future growth requires talented people. Sartorius is a dynamic organization suited to people who want to showcase skills, be recognized for expertise and thrive in a vibrant and innovative environment.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex or national origin. We are also an equal opportunity employer of individuals with disabilities and protected veterans.
Please view equal employment opportunity posters provided by OFCCP here
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About Sartorius
Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.
We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.
Join our global team and become part of the solution. We are looking forward to receiving your application.
*************************
Senior Engineer- Product & Process
Engineer Job In Juana Daz, PR
The Senior Engineer- Product & Process is responsible for supporting the Global Technical Innovations Group during the implementation of capacity expansion projects, selection and definition of future manufacturing platforms, modifications of existing technology or introduction of new products on current manufacturing lines. These projects include but are not limited to activities such as product and processes setup and evaluation, capacity analysis evaluation, concepts definition, vendor technical discussions, prototyping testing, and user requirements definitions.
Scope - Actively participate, assist, and/or be accountable in the planning and execution of mid- to high-complexity development and troubleshooting activities for new and existing products or processes. Product & process support may include end-to-end new product, equipment, process, materials development, enhancement, and studies,
What you will do:
* Support problem solving and root cause analysis activities following the DMAIC methodology
* Execute process development strategy and implementation plan
* Own process data statistical analysis and execute characterization activities
* Provide recommendations based on process data analysis
* Engage in development of automation and equipment concepts
* Participate proof of concept definition and execution
* Assist in equipment process setup guides
* Actively contribute in process and technology benchmarking activities
* Facilitate engineering studies definition and execution
* Process development activities for new and existing products and equipment
* Support equipment commissioning
* Support equipment and process qualification activities
* Support equipment performance monitoring and evaluation
* Collaborate with technical team and vendors assigned.
* Other duties as assigned.
Required Qualifications:
* Strong project management and technical writing skills
* Knowledge and/or exposure to QSR regulations
* Bilingual (English/ Spanish).
* Strong oral and written communication skills.
* Strong presentation skills
* Personal computer knowledge (MS Office suite)
* Knowledge of Good Laboratory Practices (GLP, part 58) and GMP.
* Safety regulation knowledge (OSHA)
* Ability to work overtime and weekends when necessary
Preferred Qualifications:
* Minitab statistical software proficiency.
* Lean Six Sigma certification.
* Knowledge and experience working with business intelligence tools, such as Tableau or PowerBI.
Experience:
* Five years of experience and exposure in manufacturing process within the regulated industry.
Education:
* Bachelor's degree in engineering required. Chemical, Mechanical, Electrical, Industrial Engineering majors preferred.
* EIT license highly desirable and CIAPR member.
CooperVision Manufacturing Puerto Rico LLC is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
#LI-LL2 #onsite
Network Operations Engineer
Engineer Job In Isabela, PR
Perform Corrective Maintenance, alarm clearing, Troubleshooting and resolution Installation, commissioning and integration of Telecom and transport equipment to cater business requirements. Network management and alarm monitoring Fault Ticket Work Order Clearing
Make Your Passion Part of Your Profession. Attracting the best and brightest Talents is pivotal to our success. If you are ready to share our purpose of Creating a Globe of Good, explore opportunities with us.
Project Engineer
Engineer Job In Florida, PR
Overview COMPANY OVERVIEW: MasTec's Clean Energy and Infrastructure Group (CE&I) is a $4 billion annual revenue business unit that provides construction services for industrial facilities; building products manufacturers, power generation facilities, manufacturing plants; solar, wind, and thermal energy plants; buildings, and infrastructure. Within the CE&I group, the MasTec Industrial sector includes sister companies Casey Industrial, Phoenix Industrial and Mastec Industrial. This collective industrial group provides a merit shop, multi-craft industrial contractor with the ability to self-perform all major craft trades that ensures greater safety, quality, flexibility, and economy in delivering the work required to complete each project. The collective experience and knowledge of this team provides comprehensive project development, pre-construction planning, and project management with the mastery to successfully manage projects that meet deliverable and budgetary requirements. With every project, we commit to providing the highest levels of quality, safety, and value. Location & Travel Details: You can be based in any city or state in the U.S.. This is a traveling, project based position, up to 90% of the time. You have the potential to be placed on a project site located in any state throughout the US. You'll spend 8-18 months on average per project. We offer designated per diem in addition to an excellent base salary to support and help you cover living expenses. This position is eligible for mobilization support (may include mileage reimbursement), and includes one longer weekend every four weeks for additional time at home. A company vehicle and fuel card OR vehicle allowance will be provided. At MasTec Industrial, we are committed to attracting, developing and retaining the best talent. No matter your role, you will have the opportunity to contribute to our success as we deliver innovative solutions to our clients. The Sr. Project Engineer I role will oversee and execute the project controls and management of a multiple discipline, EPC project. Your main functions will include (but not limited to) responsibility for the full scope of the project such as direct support to a Sr. Project Engineer II installed quantity monitoring, contract administration, project planning and scheduling, procurement, and project reporting. The Sr. Project Engineer I role requires interfacing with all areas affected by the project including the client(s), engineering/design, subcontractors, distributors, equipment vendors, and the ongoing strategic communication with project management regarding the status of the project. Responsibilities ESSENTIAL JOB FUNCTIONS: Represent in a professional manner in all client interaction activities. Provide the client with contract required reports (weekly, monthly, schedule.) Champion Corporate Safety Plan and help develop the site-specific safety plan. Create quantity calculation formulas to accurately determine percentage of completed/installed materials. Develop a process for the creation and review of work plans and work packages. Provide support to ensure the site quality plan is communicated and all inspections and quality documentation is being completed on time and assembled for final turn over. Manage the compilation, processing, and customer approval of daily labor timesheets. Review and train people the correct usage of Job Safety Analysis (JSA's) Lead jobsite safety reviews, toolbox meetings, mass safety meetings, and safety training. Track material deliveries and develop procurement status report. Plan, schedule, and coordinate work groups on the jobsite. Direct other to perform material takeoffs from drawings, specifications, and other contract documents. Perform complex engineering calculations and technical drafting to support field operations. Direct Field Engineers to gather and prepare data for submittal or transmittal to the customer, vendors, subcontractors, governmental agencies, and internal use. Review field issued purchase orders and subcontracts, prepare material buyout take offs from issued for construction drawings. Direct home office performed procurement and subcontract administration functions. Provide field support and supervise subcontractor operations. Manage all project recordkeeping and correspondence functions including daily reports, photographs, requests for information (RFIs), submittal, transmittal, memorandums, and other contract required correspondence. Create and closely monitor project controls such as productivity tracking including Average labor rate, indirect scheduling, equipment schedule and log, risk, and opportunity log, etc. Create and maintain master project schedule. Generate change orders and as-built data to be reviewed by the Project Manager. Drive the planning process through the master schedule, 6-week, 3-week, 1-week, and manpower curves. Administering Accounting/Job Costs/Work in Progress (WIP) Updates: Learn and Assist the Project Manager with these activities. Lead the budgeting process of taking the Estimate and converting it to the Standard Phase codes. Alert Project Manager and Home Office of trends regarding labor, material, subcontractor and equipment costs. Accurately manage the cost forecasting process for entire project (labor, materials, subcontractors, equipment.) Identify trends and suggest corrective actions when needed. Establish the cashflow forecast and curve to ensure positive cashflow for the project. Act as primary company representative in the absence of or as directed by Project Manager. Know all of the provisions, terms and scope of the Prime contract. Develop and prepare Schedule of Values and all Invoices to customer. Manage, lead direct reports, and mentor. SUPERVISORY: Support a crew of 100 people for short periods if needed. Lead/Direct a team of 1 or more Field Engineers. Oversee and manage all the field office staff, which could include engineers, office manager, document control, schedulers, procurement, warehouse, and other support personnel on the project. Qualifications EDUCATION AND WORK EXPERIENCE REQUIREMENTS: Bachelor's degree in engineering, construction management, or related. 7 plus years' experience as a Field Engineer or similar role. KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED: Be knowledgeable of MIC Health and Safety programs and project specific regulations. When on-site, actively participate in daily toolbox meetings with crews and subcontractors. Set a personal example of safe behavior. Ability to read, analyze and identify discrepancies on engineering plans, specifications, and contract documents. Provide constructability and cost saving alternatives at design phase of project. Ability to freely access all points of a construction site in wide-ranging climates and environment. Highly motivated, with a demonstrated passion for excellence and taking initiative. Strong work ethic, willing to do what it takes to get the job done right the first time. Demonstrated commitment to ethics and integrity. Passion for safety, with the ability to help us ensure that nobody gets hurt. Leader with the ability to delegate work and provide support as needed to meet deadlines, goals, and objectives. Willing to travel extensively and relocate to the next project location for an extended period (typically 6-12 months.) Other may duties may be assigned Maintain in-depth relations with all members of their team and your supervisor. PHYSICAL DEMANDS: Work up to a 12-hour shift doing hard physical work in varying temperatures and outside conditions. May need to maintain physical strength and stamina; Use arms, hands, and legs fully; Push, pull, and frequently lift and carry objects weighing up to 50 pounds; and stoop, kneel, balance, crouch, crawl, and climb to perform job tasks. Stamina to perform this task repetitively and continuously for several hour intervals. Uncontrolled environmental conditions: Constant change in weather and site conditions. This work environment may involve moderate exposure to unusual elements, such as extreme temperatures, dirt, dust, fumes, smoke, unpleasant odors and/or loud noises. Ability to wear personal protective equipment is required (including but not limited to- safety toed shoes, gloves, safety glasses, hearing protection, hardhat, vest, etc.). Move in and around confined, cluttered, and uneven areas. May need to work at heights and must be able to abide by all safety and fall-protection requirements; must be able to wear and utilize all safety equipment required for work at heights. Evaluate information based on measurable standards; and see details in objects or drawings and recognize slight differences in shapes and shadings. Visualize objects in three dimensions from drawings. Keep good balance and work at heights. See well (either naturally or with correction). Hear well (either naturally or with correction.) Coordinate the use of eyes, hands, and feet. HOURS: This position is a Full-Time position scheduled to work typically 50 hours per week. Schedule is subject to projects requirements. TRAVEL: Travel required up to 90%. Position requires presence directly on the Project Site location with intermittent travel to residence of record. What's in it for you: Financial Wellbeing Compensation $120,000 - $160,500 per year, commensurate with experience. Competitive pay with ongoing performance review and merit increase 401(k) with company match & Employee Stock Purchase Plan (ESPP) Flexible spending account (Healthcare & Dependent care) Health & Wellness Medical, Dental, and Vision insurance (plan choice) - coverage for spouse, domestic partner, and children Diabetes Management, Telehealth Coverage, Prescription Drug Plan, Pet Insurance Family & Lifestyle Paid Time Off, Paid Holidays, Bereavement Leave Military Leave, including Differential Pay and Benefits Continuation Employee Assistance Program Planning for the Unexpected Short and long-term disability, life insurance, and accidental death & dismemberment Voluntary life insurance, accident, critical illness, hospital indemnity coverage Emergency Travel Assistance Program Group legal plan Position may be subject to pre-employment screening, which may include background check and drug testing. Accessibility: If you need an accommodation as part of the employment process, contact *********************. Due to the high volume of applications received, we are unable to respond to individual requests regarding application status. Please log into your candidate profile for up-to-date information. MasTec, Inc. is an Equal Employment Opportunity Employer/Disability/Veteran. The Company's policy is not to unlawfully discriminate against any applicant or employee on the basis of race, color, sex, sexual orientation, gender identity, religion, national origin, age, disability, genetic information, military status, or any other consideration made unlawful by applicable federal, state, or local laws. The Company also prohibits harassment of applicants and employees based on any of these protected categories. It is also MasTec's policy to comply with all applicable state, federal and local laws respecting consideration of unemployment status in making hiring decisions. Disclaimer: MasTec and our Subsidiaries will never ask prospective employees for any form of payment or money transfer as part of job application or onboarding. We do not ask prospective employees for information about credit cards or personal passwords, and it does not require applicants to purchase equipment or software. Ensure that all recruiter email addresses end in @mastec.com or @talent.icims.com. If you suspect you are the target of a scam, we advise you to contact your local law enforcement agency and report fraud at ***************************** MasTec Clean Energy & Infrastructure and our subsidiaries do not work with any third-party recruiters or agencies without a valid signed agreement and partnership with the Corporate Talent Acquisition Team. #LI-MH1 #LI-Onsite
EDUCATION AND WORK EXPERIENCE REQUIREMENTS: Bachelor's degree in engineering, construction management, or related. 7 plus years' experience as a Field Engineer or similar role. KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED: Be knowledgeable of MIC Health and Safety programs and project specific regulations. When on-site, actively participate in daily toolbox meetings with crews and subcontractors. Set a personal example of safe behavior. Ability to read, analyze and identify discrepancies on engineering plans, specifications, and contract documents. Provide constructability and cost saving alternatives at design phase of project. Ability to freely access all points of a construction site in wide-ranging climates and environment. Highly motivated, with a demonstrated passion for excellence and taking initiative. Strong work ethic, willing to do what it takes to get the job done right the first time. Demonstrated commitment to ethics and integrity. Passion for safety, with the ability to help us ensure that nobody gets hurt. Leader with the ability to delegate work and provide support as needed to meet deadlines, goals, and objectives. Willing to travel extensively and relocate to the next project location for an extended period (typically 6-12 months.) Other may duties may be assigned Maintain in-depth relations with all members of their team and your supervisor. PHYSICAL DEMANDS: Work up to a 12-hour shift doing hard physical work in varying temperatures and outside conditions. May need to maintain physical strength and stamina; Use arms, hands, and legs fully; Push, pull, and frequently lift and carry objects weighing up to 50 pounds; and stoop, kneel, balance, crouch, crawl, and climb to perform job tasks. Stamina to perform this task repetitively and continuously for several hour intervals. Uncontrolled environmental conditions: Constant change in weather and site conditions. This work environment may involve moderate exposure to unusual elements, such as extreme temperatures, dirt, dust, fumes, smoke, unpleasant odors and/or loud noises. Ability to wear personal protective equipment is required (including but not limited to- safety toed shoes, gloves, safety glasses, hearing protection, hardhat, vest, etc.). Move in and around confined, cluttered, and uneven areas. May need to work at heights and must be able to abide by all safety and fall-protection requirements; must be able to wear and utilize all safety equipment required for work at heights. Evaluate information based on measurable standards; and see details in objects or drawings and recognize slight differences in shapes and shadings. Visualize objects in three dimensions from drawings. Keep good balance and work at heights. See well (either naturally or with correction). Hear well (either naturally or with correction.) Coordinate the use of eyes, hands, and feet. HOURS: This position is a Full-Time position scheduled to work typically 50 hours per week. Schedule is subject to projects requirements. TRAVEL: Travel required up to 90%. Position requires presence directly on the Project Site location with intermittent travel to residence of record. What's in it for you: Financial Wellbeing Compensation $120,000 - $160,500 per year, commensurate with experience. Competitive pay with ongoing performance review and merit increase 401(k) with company match & Employee Stock Purchase Plan (ESPP) Flexible spending account (Healthcare & Dependent care) Health & Wellness Medical, Dental, and Vision insurance (plan choice) - coverage for spouse, domestic partner, and children Diabetes Management, Telehealth Coverage, Prescription Drug Plan, Pet Insurance Family & Lifestyle Paid Time Off, Paid Holidays, Bereavement Leave Military Leave, including Differential Pay and Benefits Continuation Employee Assistance Program Planning for the Unexpected Short and long-term disability, life insurance, and accidental death & dismemberment Voluntary life insurance, accident, critical illness, hospital indemnity coverage Emergency Travel Assistance Program Group legal plan Position may be subject to pre-employment screening, which may include background check and drug testing. Accessibility: If you need an accommodation as part of the employment process, contact *********************. Due to the high volume of applications received, we are unable to respond to individual requests regarding application status. Please log into your candidate profile for up-to-date information. MasTec, Inc. is an Equal Employment Opportunity Employer/Disability/Veteran. The Company's policy is not to unlawfully discriminate against any applicant or employee on the basis of race, color, sex, sexual orientation, gender identity, religion, national origin, age, disability, genetic information, military status, or any other consideration made unlawful by applicable federal, state, or local laws. The Company also prohibits harassment of applicants and employees based on any of these protected categories. It is also MasTec's policy to comply with all applicable state, federal and local laws respecting consideration of unemployment status in making hiring decisions. Disclaimer: MasTec and our Subsidiaries will never ask prospective employees for any form of payment or money transfer as part of job application or onboarding. We do not ask prospective employees for information about credit cards or personal passwords, and it does not require applicants to purchase equipment or software. Ensure that all recruiter email addresses end in @mastec.com or @talent.icims.com. If you suspect you are the target of a scam, we advise you to contact your local law enforcement agency and report fraud at ***************************** MasTec Clean Energy & Infrastructure and our subsidiaries do not work with any third-party recruiters or agencies without a valid signed agreement and partnership with the Corporate Talent Acquisition Team. #LI-MH1 #LI-Onsite
ESSENTIAL JOB FUNCTIONS: Represent in a professional manner in all client interaction activities. Provide the client with contract required reports (weekly, monthly, schedule.) Champion Corporate Safety Plan and help develop the site-specific safety plan. Create quantity calculation formulas to accurately determine percentage of completed/installed materials. Develop a process for the creation and review of work plans and work packages. Provide support to ensure the site quality plan is communicated and all inspections and quality documentation is being completed on time and assembled for final turn over. Manage the compilation, processing, and customer approval of daily labor timesheets. Review and train people the correct usage of Job Safety Analysis (JSA's) Lead jobsite safety reviews, toolbox meetings, mass safety meetings, and safety training. Track material deliveries and develop procurement status report. Plan, schedule, and coordinate work groups on the jobsite. Direct other to perform material takeoffs from drawings, specifications, and other contract documents. Perform complex engineering calculations and technical drafting to support field operations. Direct Field Engineers to gather and prepare data for submittal or transmittal to the customer, vendors, subcontractors, governmental agencies, and internal use. Review field issued purchase orders and subcontracts, prepare material buyout take offs from issued for construction drawings. Direct home office performed procurement and subcontract administration functions. Provide field support and supervise subcontractor operations. Manage all project recordkeeping and correspondence functions including daily reports, photographs, requests for information (RFIs), submittal, transmittal, memorandums, and other contract required correspondence. Create and closely monitor project controls such as productivity tracking including Average labor rate, indirect scheduling, equipment sche
Project Engineer
Engineer Job In Arecibo, PR
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
**Project Engineer (This is a Pipeline requisition for future Project Engineer Opportunity at Abbott)**
**About Abbott**
Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.
**The Opportunity**
This position works out of our Arecibo location in the CRM division.
As the Project Engineer, you will Manage all aspects of an engineering project, from start to finish, so that it is completed on time and within budget.
**What You'll Do**
+ Design, communicate, and implement an operational plan for completing the project.
+ Monitor progress and performance against the project plan.
+ Take action to resolve operational problems and minimize delays.
+ Identify, develop, and gather the resources to complete the project.
+ This may include preparing engineering designs and work specifications, developing project schedules, budgets and forecasts, and selecting materials, equipment, project staff, and external contractors.
+ Liaise with other operational areas in the organization (e.g., engineering, drafting, technical) to secure specialized resources and contributions for the project.
+ Select and manage the activities of contractors to ensure they are integrated into the project and the organization receives satisfactory standards of service.
+ Conduct meetings and prepare reports to communicate the status of the project.
+ Set priorities, allocate tasks, and coordinate project staff to meet project targets and milestones.
**Required Qualifications**
+ B.S. in Engineering
+ Minimum of three (3) years of experience.
**Preferred Qualifications**
+ Previous experience in regulated environment, preferable medical devices.
Apply Now (*************************
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at ************** , on Facebook at *********************** and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is $53,300.00 - $106,700.00. In specific locations, the pay range may vary from the range posted.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call ************ or email ******************
Manufacturing Engineer
Engineer Job In Ponce, PR
Responsibilities may include the following and other duties may be assigned. Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations.
Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills.
DIFFERENTIATING FACTORS
Established and productive individual contributor. Works independently with general supervision on larger, complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal and external contacts. External interactions are mostly problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making. Leadership and Talent
Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires an Engineering Degree (Mechanical Engineering preferred) and a minimum of 2 years of relevant experience.
As part of the ME responsibilities, the person should be able to evaluate product, components and process (automated assembly lines, with automated inspections). The ME should be able to generate and evaluate Design of Experiments and other statistical tools required during the validation of the equipment or as part of Non-conformance evaluations. GMP and validations knowledge. The person should have initiative, team player, action oriented and great communication skills.
1. Troubleshooting process and equipment (electrical and mechanical) / Problem solving
2. Read and interpretate schematics
3. Automation inspection knowledge
Education Required: Engineering, Mechanical Engineering Preferred
Manufacturing Engineer II
Engineer Job In Aasco, PR
Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
1.Development and update of manufacturing process flow chart.
2.Maintenance and update of manufacturing documentation such as: BOM/production routers, procedures, drawings, specifications, etc.
3.Maintenance and upgrade existing products/processes.
4.Develops and/or executes validations of revised/new raw materials, products, processes and/or equipment following Integra procedures.
5.Develops, coordinates, and implements the change controls related to each manufacturing engineering project. Evaluates and assures completeness of change control requirements for projects under responsibility.
6.Develops the required documentation, procedures, drawings, protocols, engineering change notices, technical reports and other information as required by the company.
7.Submits requisitions of components, materials, equipment, machinery, services, tooling and fixtures to supervisor for approval as part of engineering projects.
8.Oversee installations to ensure machines and equipment are installed and functioning according to specifications. Troubleshoots equipment/processes that do not perform as intended.
9.Provides engineering technical support to manufacturing areas.
10.Develops and implements scrap reduction initiatives.
11.Develops and implements capacity increase projects.
12.Evaluates and update manufacturing time standards.
13.Develops and implements cost improvement projects.
14.Analyzes layout of equipment, workflow, assembly methods, and work force utilization standards to maximize the manufacturing processes efficiency.
15.Evaluates and implements product labeling and printed materials changes.
16.Evaluates and implements raw material/components changes.
17.Evaluates and/or implements change controls and engineering change orders (ECO, DCO, MCO).
18.Evaluates, investigates and documents non-conformances incidents. Provides support on the assessment and disposition of non-conforming material.
19.Completes assigned Non-Conformance and CAPA investigations and prepare investigation reports.
20.Implementation of corrective and preventive actions for process related concerns.
21.Supports in the investigation and resolution of supplier quality issues.
22.Supports the introduction of new businesses and products/processes.
23.Participates in the development of the new processes, process transfers and continuous improvement, and issue resolution.
24.Supports the transfer of products/processes to outside facilities.
25.Development of process controls for new and existing equipment and/or processes.
26.Reviews and approves validations and completion reports for new and existing products, processes and equipment.
27.Develops and implements metrics to monitor the performance of manufacturing areas.
28.Develops and implements Six Sigma/Lean projects and quality improvement plans. Identify and implement opportunities for continuous improvement.
29.Develops and conducts product/process training programs and demonstrates skills to trainees, using hand tools, precision measuring instruments, following schematics, drawings, procedures, and manufacturer's specifications.
30.Prepares information for Quality Management Reviews and Operational Reviews such as: trending charts, Pareto analysis, etc.
31.Participates in the compilation and review of technical documentation for both domestic and international regulatory submissions.
32.Participates in external audits such as: FDA, Notified Body (BSI) and Corporate, among others.
33.Will partner with Manufacturing and Quality departments to ensure that the development, manufacture and distribution of medical products is in compliance with corporate policies and regulatory requirements (International Organization for Standardization (ISO)/ European Norm (EN)/ European Medical Device Directive (MDD)/ Canadian Medical Device Regulation (CMDR) standards/ sections, Quality System Regulation (21CFR 820, 21CFR 11 and other associated FDA regulations), and other applicable regulatory agencies).
34.Performs other related duties as necessary.
DESIRED MINIMUM QUALIFICATIONS - Education and Experience
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
* BS in Engineering, preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical.
* Master's degree is a plus.
* PE License strongly desired.
* Lean/Six Sigma Green or Black Belt Certification is a plus.
* Minimum of 3 - 5 years of experience in the medical device and/or pharmaceutical manufacturing environment; with at least three (3) years in a manufacturing process or quality engineering position and preferably with exposure to Design Control and Product/Process Transfer.
* Knowledge in Collagen and Silicone technologies and materials as well as lyophilization and dispersion preparation is highly desirable.
* Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements.
* Knowledge in Organizational Excellence and Lean/Six Sigma.
* Strong Project Management skills.
* Effective knowledge in Microsoft Project software.
* Knowledge of cost control, and development of guidelines, training, and maintenance programs.
* Ability to lead teams through complex projects and provide departmental technical leadership.
* Must have excellent communication skills and a strong track record of working cross-functionally.
* Must have demonstrated ability to think strategically.
* Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others.
* Experience in Design Control procedures and regulation is desirable.
* Teamwork oriented and self-starter.
* Fully bilingual (English and Spanish).
* Availability to work extended hours in the day and weekends as required.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law | EOE including Disability/Protected Veterans
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at *********************** or call us at ************.
Integra - Employer Branding from Integra LifeSciences on Vimeo
Manufacturing Engineer
Engineer Job In Aasco, PR
For Project Validation services in the Engineering & Manufacturing areas.
WHAT MAKES YOU A FIT:
The Technical Part:
Bachelor's Degree in Engineering or Science and at least four (4) years of exposure to Manufacturing activities within the Pharmaceutical or Medical Devices industry.
Ability to lead teams through complex projects and provide departmental technical leadership.
Bilingual (Spanish and English)
Shift: Administrative & according to business needs
Experience in:
Validations such as manufacturing equipment, manufacturing processes, stability, or aging, are required.
Technical documentation such as Change Controls, Validation Plans, Validation Protocols, Technical/investigation reports, SOP, and others.
GMP & GDP regulations
The Personality Part:
Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
Participate on cross-functional project teams including R&D, Quality Assurance, Supplier Quality, Planning, Purchasing, Regulatory, and manufacturing to maintain and improve surgical products.
Responsible for reviewing and updating applicable product specifications and drawings for legacy products. Responsible for identifying acceptance criteria for product specifications.
Develop project plans for qualifications and ensure team resources identified, team members help accountable to deliverables, and milestones met.
Provide engineering knowledge and resolve design, manufacturing, and quality-related problems impacting existing products.
Develop and issue change control documentation to address changes in components and/or raw materials requested by the suppliers following applicable procedures.
Ability to adjust priorities when with shifting business needs.
Support manufacturing process improvements for CSS products in both internal manufacturing facilities and in partnership with external suppliers.
Provide project leadership to improve existing products and associated manufacturing processes.
Support the selection and validation of replacement materials, such as polymers, metals, and adhesives, for CSS applications.
Support corrective actions and the implementation of all corrective actions to ensure improvements are attained.
WHO WE ARE:
We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS!
Are you the Next Piece?
Validation Engineer
Engineer Job In Aasco, PR
PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning and Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.
Job required Qualification:
Bachelor of Science degree, Engineering, or Equivalent training and experience.
More than 5 years of experience in a regulated environment.
3 years of experience authorizing procedural and commercial marketing documents.
More than 3 years of experience with clean rooms, aseptic suites, single-use technology, bioreactors, and cell culture.
Experience in mechanic and Industrial engineering
Strong working knowledge of pharmaceutical industry regulations (GMP, GDP, ICH, etc.)
Strong understanding and working knowledge of project lifecycle, entrepreneurial mindset, and excellent written and verbal communication skills.
Strong relationship management, leadership, and organizational skills.
Strong working knowledge in Microsoft suites, and Smartsheet.
Job responsibilities and Duties:
Develop and execute equipment qualification protocols for all manufacturing, processing, and packaging equipment and facilities/utilities supporting these operations.
Develop and execute process validation protocols for all manufacturing and packaging processes of commercial products (and R&D products as applicable).
Develop and execute validation/verification protocols for all commercial and R&D manufacturing, processing, and packaging equipment.
Analyze data, utilizing statistical methods, generated by validation studies performed by the Validation group to determine process capabilities.
Gather photocopies and compile relevant documentation such as executed batch records, certificates of analysis, equipment logs, equipment qualifications, raw material certificates of analysis.
Investigate and resolve deviations/exceptions from the predefined acceptance criteria.
Draw conclusions from data, observations, deviation/exception, and investigation as to whether the process is considered valid.
Write summary reports (closeout report when applicable) for validation/qualification protocols following criteria as outlined within the validation/qualification procedures and policies.
Maintain protocols and system documentation in an orderly library so that information can be provided to regulatory bodies in a timely manner.
Ensure protocols, verifications, validation plans, and summary reports generated during validation/ qualification activities are stored according to the procedure.
Maintain current knowledge in the areas of compliance and validation and other regulatory issues that may impact the Company. Work proactively to maintain the highest level of compliance in all areas. Gather current knowledge from QA/QC, regulatory, periodicals, and/or appropriate training programs.
Interact and coordinate compliance efforts with other departments including, but not limited to, Operations, Engineering, QA, laboratories (QC and R&D), and R&D to provide a high degree of assurance that all qualification/validation activities, where appropriate, are completed.
Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
Perform other related duties as assigned to meet departmental and Company objectives.