Engineer Jobs in Monroe, NJ

Job Title: Automation Engineer Status: Full-time direct hire Compensation: $120,000 to $140,000 DOE Individuals will be responsible for installing, maintaining, and troubleshooting the automation systems for automated utility, processing, filling, inspection, and packaging equipment. The system will be PLC, SCADA, and PC based. The individual will be expected to perform system administration (access control, software revision control, back-up and recovery), and perform troubleshooting for malfunctioning systems. The individual will be responsible for specifying control system and control system documentation requirements for new systems. The individual will be responsible for reviewing functional specifications for both hardware and software for new automated systems for process, filling, utilities, packaging, and inspection equipment. Individual will be responsible for specifying and troubleshooting vision inspection systems. Individuals should be capable of preparing a preferred vendors list for control system hardware. Individuals will be responsible for specifying and troubleshooting instrumentation. The actual programming of systems will be minimal, but the individual is expected to be able to make minor modifications to code and HMI graphics for smaller in-house changes, therefore the individual must be able to read logic and perform some programming as well as update control system documentation. Individual must be capable of reading and understanding electrical control system diagrams (control panel wiring diagrams, loop drawings, panel layout drawings and schedules, etc.). Individuals must be comfortable walking down control system diagrams and red-lining them to reflect as built conditions. ACAD and networking experience a plus, but not an absolute requirement. Understand 21 CFR Part 11, cGMP, and other regulatory guidance associated with computer / automation-based systems. Provide support for the engineering and design of automated systems Understand and read complex ladder logic Understand PLC/ PC based controllers and functionality Troubleshoot low voltage control wiring Working knowledge of vision inspection systems and related quality Define requirements for vendor design documentation. Generate user requirement specifications for control systems. Review vendor automation design documentation (FRS, DDS, requirements traceability matrix, code, and logic). Working knowledge of vision inspection systems and related quality processes in a GMP environment. Review qualification protocols of automated systems. Support the execution of the qualification of automated control systems. Proficient in reading and interpreting electrical schematics for troubleshooting and repair Prepare risk assessments for automated systems. Prepare Change Controls associated with changes to control systems Able to perform complex assessments for computer systems against current industry compliance requirements Qualifications A bachelor's degree in engineering (e.g., electrical, mechanical, or control systems engineering) or a related field with 5-7 years of experience in automation and controls in a pharmaceutical environment is typically required. Knowledge of input/output control sequences, PLC logic, control loops, and sequencing. Basic understanding of SQL servers, databases, networking, and Excel automation. Familiarity with industry practices and guidelines (FDA, ISO, EU, ICH).

JOB TITLE: Equipment Engineer Duration: 12 months initial (potential extension/potential right to hire) Top Skills: Equipment Engineer: Executes equipment calibration, preventative maintenance, performance verification, troubleshooting and repair activities in laboratory and manufacturing areas, as required per current scheduling (CMMS) System. Escorts and supervises vendors for calibration, preventative maintenance, performance verification and repair functions as required per current scheduling (CMMS) System. Reviews and approves vendor executed calibration, maintenance, repair, and performance verification records for accuracy, and completeness. Owns and supports deviations and investigations that result from calibration or performance verification activities, along with developing and supporting the implementation of corrective and preventive actions. Documents and populates calibration/maintenance information in WPT (Work Plan Template) or MDT (Measurement Data Template) using CMMS system. Executes requalification on Controlled Temperature Units (ex. Refrigerators, Freezers (which includes -20°C / -80°C Freezers), Incubators, Cryotanks, Cryopods, and Storage Rooms/Areas). Supports multiple sites within Warren and Summit. Supports clinical manufacturing on-call equipment troubleshooting activities during weekends as required. 1. PURPOSE AND SCOPE OF POSITION: The LSM Equipment Engineer supports the successful operation of laboratory and clinical manufacturing operations at their home sites through interaction with internal team members and internal customers, and external service providers. The incumbent conducts tasks assigned by the management independently or with minimum supervision. The LSM Equipment Engineer is responsible for initiating and owning deviations, CAPAs, and change controls, and authoring calibration and maintenance SOPs as well as performing calibrations, maintenance, and qualifications/validations. 2. REQUIRED COMPETENCIES: • Knowledge of cGMP, GXP, GAMP, including 21CFR part 11, computer systems validation requirements and good documentation practices. • Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment. • Knowledge of calibration management and environmental monitoring systems. • Strong critical thinking skills and the ability to work independently. • Excellent interpersonal and communication skills with experience dealing with a diverse workforce where individual initiative, accountability to the team, and professional maturity are required. • Strong multi‐tasking and organizational ability. Ability to effectively manage multiple tasks and activities simultaneously. • Proficiency in Microsoft Office Suite - Word, Excel, PowerPoint, and Outlook; innate ability to learn new software, such as corporate intranet and enterprise applications. • Working knowledge of scheduling software and systems, and inventory management systems, e.g., Blue Mountain RAM and/or Maximo Computerized Maintenance Management System (CMMS) preferred. • Ability to interact effectively with QC, Manufacturing, QA, and Engineering & Facilities groups. 3. DUTIES AND RESPONSIBILITIES Operational Activities • Executes equipment calibration, preventative maintenance, performance verification, troubleshooting and repair activities in laboratory and manufacturing areas, as required per current scheduling (CMMS) System. • Escorts and supervises vendors for calibration, preventative maintenance, performance verification and repair functions as required per current scheduling (CMMS) System. • Reviews and approves vendor executed calibration, maintenance, repair, and performance verification records for accuracy, and completeness. • Documents and populates calibration/maintenance information in WPT (Work Plan Template) or MDT (Measurement Data Template) using CMMS system. • Modifies or update CMMS documentation as required. • Prepares reports and keeps records on calibration inspection, testing, and repairs. • Executes requalification on Controlled Temperature Units (ex. Refrigerators, Freezers (which includes -20°C / -80°C Freezers), Incubators, Cryotanks, Cryopods, and Storage Rooms/Areas). • Supports multiple sites within Warren and Summit. • Supports clinical manufacturing on-call equipment troubleshooting activities during weekends as required. • Ensures all calibration, PM, and performance verification records are filed appropriately after approval. • Contacts supplier for quotation on external calibration/PM of the equipment and calibration standards • Initiates, participates, and assists in resolution of quality investigations. • Authors and supports the development, revision, and review of written Standard Operating Procedures (SOP) for calibration, preventive maintenance, and performance verification of instruments/equipment. • Supports the development, review and approval of calibration and maintenance plans in site CMMS system. • Supports the execution of process improvement studies, as required. • Adheres to written policies and procedures governing the LSM department activities and the equipment they manage to ensure compliance with approved standards. • Performs inventory of the equipment and/or standards in the labs as required. • Maintains a positive relationship with the site customers and outside vendors while promoting a positive team environment. • Participates actively in special projects as required. • Ensure low cost of the Laboratory Systems Management (LSM) department (Reducing overtime, implementing innovative ideas) • Plans, justify and implement cost reduction small projects. • Usage of several test equipment and tools (e.g., pressure gauges, temperature, humidity meters, flow meters, particle counters and temperature mapping equipment etc.) • Owns and supports deviations and investigations that result from calibration or performance verification activities, along with developing and supporting the implementation of corrective and preventive actions. • Support the development, review and approval of calibration and maintenance plans in site CMMS system. • Follows cGMP (current Good Manufacturing Practices) and ALCOA principles ('ALCOA' defines that data should be Attributable, Legible, Contemporaneous, Original, and Accurate) In addition, 'ALCOA+' guidance recommends that data is also Complete, Consistent, Enduring, and Available. Inventory Management • Work with Planning group to ensure system is updated as calibration, maintenance and performance verification activities are performed. • Approves Change Request, Asset Inductions, and Work Request. • Approving Calibration and Maintenance forms. • Perform Client's investigations. • Review and approve calibration and maintenance work. Regulatory Responsibilities • Maintains all required Corporate, Facilities and EHS training as required. • Adheres to all safety procedures and hazard communication. • May be called upon to act as SME in both internal and regulatory audits. 4. EDUCATION AND EXPERIENCE • BS in Engineering or Science related discipline preferred. • Minimum 3 years of experience in FDA-regulated industry. • Minimum 3 years of experience working directly with laboratory equipment (ex. centrifuges, temperature/humidity meters, balances, freezers, refrigerators etc.) • Maintenance coordination / planning experience preferred. • Experience working in a clinical environment preferred. 5. WORKING CONDITIONS: Physical / Mental Demands: • Occasional stooping, bending, stretching, pushing, pulling, reaching, and/or lifting up to 25 lbs. • Ability to sit, stand, walk, and move within workspace for extended periods. • Ability to perform repetitive tasks, including hand to finger manipulations, grasping, pushing, and pulling. Environmental Conditions: • Environment may include working in office, laboratory, or manufacturing area. • Donning proper gowning and/or PPE such as safety glasses and shoes in an environment with hazardous materials and waste will be required. • Working safely and effectively when working alone or working with others will be required. This is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management. Additional Job Requirements: Position Handles Hazardous Materials If hired, you will enjoy the following Eclaro Benefits: 401k Retirement Savings Plan administered by Merrill Lynch Commuter Check Pretax Commuter Benefits Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro If you feel you are qualified with the required skills and if you are interested, please free to send your word version most updated resume TAILORED to the job description above to *************** or call *************. Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Sunrise System Inc. is currently looking for Equipment Engineer at Warren, NJ, Onsite with one of our top Pharma Client Job Title: Equipment Engineer Duration: 12 Month Contract (Possible extension) Position Type: Hourly contract Position (W2 only) Pay Rate: $50/Hr - $53/Hr Job Description: 1. PURPOSE AND SCOPE OF POSITION: The LSM Equipment Engineer supports the successful operation of laboratory and clinical manufacturing operations at their home sites through interaction with internal team members and internal customers, and external service providers. The incumbent conducts tasks assigned by the management independently or with minimum supervision. The LSM Equipment Engineer is responsible for initiating and owning deviations, CAPAs, and change controls, and authoring calibration and maintenance SOPs as well as performing calibrations, maintenance, and qualifications/validations. 2. REQUIRED COMPETENCIES: • Knowledge of cGMP, GXP, GAMP, including 21CFR part 11, computer systems validation requirements and good documentation practices. • Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment. • Knowledge of calibration management and environmental monitoring systems. • Strong critical thinking skills and the ability to work independently. • Excellent interpersonal and communication skills with experience dealing with a diverse workforce where individual initiative, accountability to the team, and professional maturity are required. • Strong multi‐tasking and organizational ability. Ability to effectively manage multiple tasks and activities simultaneously. • Proficiency in Microsoft Office Suite - Word, Excel, PowerPoint, and Outlook; innate ability to learn new software, such as corporate intranet and enterprise applications. • Working knowledge of scheduling software and systems, and inventory management systems, e.g., Blue Mountain RAM and/or Maximo Computerized Maintenance Management System (CMMS) preferred. • Ability to interact effectively with QC, Manufacturing, QA, and Engineering & Facilities groups. 3. DUTIES AND RESPONSIBILITIES Operational Activities • Executes equipment calibration, preventative maintenance, performance verification, troubleshooting and repair activities in laboratory and manufacturing areas, as required per current scheduling (CMMS) System. • Escorts and supervises vendors for calibration, preventative maintenance, performance verification and repair functions as required per current scheduling (CMMS) System. • Reviews and approves vendor executed calibration, maintenance, repair, and performance verification records for accuracy, and completeness. • Documents and populates calibration/maintenance information in WPT (Work Plan Template) or MDT (Measurement Data Template) using CMMS system. • Modifies or update CMMS documentation as required. • Prepares reports and keeps records on calibration inspection, testing, and repairs. • Executes requalification on Controlled Temperature Units (ex. Refrigerators, Freezers (which includes -20°C / -80°C Freezers), Incubators, Cryotanks, Cryopods, and Storage Rooms/Areas). • Supports multiple sites within Warren and Summit. • Supports clinical manufacturing on-call equipment troubleshooting activities during weekends as required. • Ensures all calibration, PM, and performance verification records are filed appropriately after approval. • Contacts supplier for quotation on external calibration/PM of the equipment and calibration standards • Initiates, participates, and assists in resolution of quality investigations. • Authors and supports the development, revision, and review of written Standard Operating Procedures (SOP) for calibration, preventive maintenance, and performance verification of instruments/equipment. • Supports the development, review and approval of calibration and maintenance plans in site CMMS system. • Supports the execution of process improvement studies, as required. • Adheres to written policies and procedures governing the LSM department activities and the equipment they manage to ensure compliance with approved standards. • Performs inventory of the equipment and/or standards in the labs as required. • Maintains a positive relationship with the site customers and outside vendors while promoting a positive team environment. • Participates actively in special projects as required. • Ensure low cost of the Laboratory Systems Management (LSM) department (Reducing overtime, implementing innovative ideas) • Plans, justify and implement cost reduction small projects. • Usage of several test equipment and tools (e.g., pressure gauges, temperature, humidity meters, flow meters, particle counters and temperature mapping equipment etc.) • Owns and supports deviations and investigations that result from calibration or performance verification activities, along with developing and supporting the implementation of corrective and preventive actions. • Support the development, review and approval of calibration and maintenance plans in site CMMS system. • Follows cGMP (current Good Manufacturing Practices) and ALCOA principles ('ALCOA' defines that data should be Attributable, Legible, Contemporaneous, Original, and Accurate) In addition, 'ALCOA+' guidance recommends that data is also Complete, Consistent, Enduring, and Available. Inventory Management • Work with Planning group to ensure system is updated as calibration, maintenance and performance verification activities are performed. • Approves Change Request, Asset Inductions, and Work Request. • Approving Calibration and Maintenance forms. • Perform Client's investigations. • Review and approve calibration and maintenance work. Regulatory Responsibilities • Maintains all required Corporate, Facilities and EHS training as required. • Adheres to all safety procedures and hazard communication. • May be called upon to act as SME in both internal and regulatory audits. 4. EDUCATION AND EXPERIENCE • BS in Engineering or Science related discipline preferred. • Minimum 3 years of experience in FDA-regulated industry. • Minimum 3 years of experience working directly with laboratory equipment (ex. centrifuges, temperature/humidity meters, balances, freezers, refrigerators etc.) • Maintenance coordination / planning experience preferred. • Experience working in a clinical environment preferred. Thanks & Regards, Pavithra R | Sunrise Systems Inc ************************* Website: **************************

Source One is a consulting services company and we're currently looking for the following individual to work as a consultant with our direct client, a global Utility and Energy Company in Bridgewater, NJ. This is a Hybrid role see details below. Candidates must be local to New Jersey with the ability to work onsite No Sponsorship or C2C Title: Systems Engineer Location: Bridgewater, NJ Hybrid (3 days in office, then remote) Contract Duration: 12 months, with likely extension w2 Rate: $90.00 - $110.00 hour PLEASE NOTE THIS IS NOT AN IT POSITION! Please read the job description. Description: Responsible for the quality and availability of information obtained from the Gas System Operation Center's (GSOC) 7 X 24 Gas Management & Control System (GMACS) / Supervisory Control and Data Acquisition (SCADA). They will display an existing understanding of or a demonstrated ability and willingness to learn Gas Operations in conjunction with real time technologies such as SCADA and Industrial Control Systems. In addition, they will respond to the daily reliability and security needs of system operations. Responsibilities: • Ensures maximum reliability and uptime of the SCADA system, 24 hours per day and 7 days per week. • Installs, configures, and supports SCADA applications to provide the required level of functionality for Company operations. • Responsible for the operation and maintenance of databases, historical and reporting systems associated with the primary and backup SCADA control centers. • Maintains applications that support or are supported by the SCADA system. • Investigates, analyses and corrects complex SCADA systems related problems • Guides and provides technical leadership, support and training to members of the support staff. • Keep abreast of technology, industry and business trends to ensure that appropriate technologies are being considered in the planning process that meet departmental and organizational requirements. • Maintain and apply working knowledge of Client Standards for Business Controls and Security and meet management's expectations for effective internal business controls, physical and cyber security. • Designing SCADA HMI to improve usability including line displays, tabular reporting including display updating and troubleshooting. Required Skills: • A Bachelor of Science Degree in Mechanical Engineering or a related field with a minimum of 6 years' experience, or the combined equivalent in education and experience. • Must possess the ability to read mechanical one-line diagrams and schematics. • Experience with AutoCAD, Microstation and/or other drafting software. • Understanding of dimensional, hierarchical, and relational data modeling • A working understanding of Linux. • Understanding of Cybersecurity awareness and governance practices. • Proficiency in Microsoft Office Applications • Must possess a valid U.S. driver's license and maintain a satisfactory driving record. • Must have effective problem-solving and decision-making skills, strong planning and organizing skills, must be adaptable and be results-oriented. • Must have excellent verbal and written communication skills. • Ability to prioritize and handle multiple tasks and projects concurrently. Desirable: • Experience in SCADA systems design and analysis. • Knowledge in Gas Pipeline Systems engineering • Agile delivery strategies and processes, Lean Six Sigma concepts or certifications • Experience in Operation Technology (OT) networks • Basic knowledge of computer programming (C/C++, Python, XML, bash and shell scripting) • Knowledge of one or more SQL variant, such as MySQL, MSSQL, and PostgreSQL.

Hi, Hope you are doing fine and healthy !!! I came across your resume. I have an immediate opportunity with our direct client. Please let me know if you are available/interested so we can further discuss this position. Also email me your updated resume (cherag@irionline.com) and share your best reachable contact number where I can call. You can also directly reach me on 650-264-9804. To know more about Integrated Resources, please visit us on http://www.irionline.com/.Since this is an urgent business requirement, I'd appreciate a prompt response on this. Title: CSV/Validation Engineer Location: Summit, NJ (Hybrid) Duration: 06+ Months Job Description: The CSV Engineer supports the successful implementation of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with equipment qualification and systems validation. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited Product. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization. Essential Functions: Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures. Develops protocols, and associated reports while adhering to a change management process. Supports the execution of equipment qualifications and validation protocols Supervises vendors for qualification functions. Supports equipment qualification and systems validation activities. Configures and documents the configuration of computerized systems Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls. Manages projects of varying Product and complexity. Supports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area. Independent ownership of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates. Completes all qualification and validation documentation with accuracy, completeness and compliance to Company standards. Provides excellent customer service and support. Regularly reviews, prioritizes and promptly responds to customer equipment qualification and support requests. Provides technical support and guidance on calibration and equipment qualification issues. Interfaces with customers to ensure all expectations are being met. Maintains a positive relationship with all team members and site customers while promoting a positive team environment. Knowledge, Skills & Abilities: Strong working knowledge of MS Windows client and server technologies. Working knowledge of standard networking principles and technologies Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance Ability to work with the end user to identify and document User and Functional Requirements Knowledge of pharmaceutical laboratory and manufacturing systems. Experience executing equipment qualification documents Ability to interact effectively with laboratory, QA, and Facilities groups Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously Strong written and verbal communication skills along solid presentation skills. Proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors. Experience with technical writing and document development / generation Strong computer skills in Microsoft Office Suite - Word, Excel, Visio and Outlook, and the ability to learn new software as required for equipment qualification. Education & Experience: Required BS degree in Engineering / Computer Science or any related field. Minimum 5 years of experience in FDA-regulated industry, with 5 years' experience in CSV. If you are not interested in looking at new opportunities at this time I fully understand. I would in that case be appreciative of any referrals you could provide from your network of friends and colleagues in the industry. We do offer a referral bonus that I'd be happy to extend to you if they turn out to be a great fit for my client. Thank you for your time and for your consideration. I look forward to hearing from you .

Title: Equipment Engineer Duration: 12 months with possible extension Strictly on W2 The LSM Equipment Engineer supports the successful operation of laboratory and clinical manufacturing operations at their home sites through interaction with internal team members and internal customers, and external service providers. The incumbent conducts tasks assigned by the management independently or with minimum supervision. The LSM Equipment Engineer is responsible for initiating and owning deviations, CAPAs, and change controls, and authoring calibration and maintenance SOPs as well as performing calibrations, maintenance, and qualifications/validations. 2. REQUIRED COMPETENCIES: • Knowledge of cGMP, GXP, GAMP, including 21CFR part 11, computer systems validation requirements and good documentation practices. • Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment. • Knowledge of calibration management and environmental monitoring systems. • Strong critical thinking skills and the ability to work independently. • Excellent interpersonal and communication skills with experience dealing with a diverse workforce where individual initiative, accountability to the team, and professional maturity are required. • Strong multi‐tasking and organizational ability. Ability to effectively manage multiple tasks and activities simultaneously. • Proficiency in Microsoft Office Suite - Word, Excel, PowerPoint, and Outlook; innate ability to learn new software, such as corporate intranet and enterprise applications. • Working knowledge of scheduling software and systems, and inventory management systems, e.g., Blue Mountain RAM and/or Maximo Computerized Maintenance Management System (CMMS) preferred. • Ability to interact effectively with QC, Manufacturing, QA, and Engineering & Facilities groups. 4. EDUCATION AND EXPERIENCE • BS in Engineering or Science related discipline preferred. • Minimum 3 years of experience in FDA-regulated industry. • Minimum 3 years of experience working directly with laboratory equipment (ex. centrifuges, temperature/humidity meters, balances, freezers, refrigerators etc.) • Maintenance coordination / planning experience preferred. • Experience working in a clinical environment preferred.

Coordinates with Production, Quality, Maintenance, and other personnel as needed to manage projects, capacity increases, and process improvements. This staff member will be responsible to plan, manage, and execute the start-up, commissioning, and validation of new or modified equipment trains with senior validation engineers to create company cleaning and process validation master plans, and other projects. The Validation Engineer will write and execute validation protocols, such as Installation, Operational, and Performance Qualifications (IOPQs), and Utilities Qualification. Projects and duties will be completed in compliance with applicable cGMP, FDA, and all other regulatory agencies standards. Coordinates Validation Program activities in compliance with our policy and department, local procedures and regulatory expectations. RESPONSIBILITIES Provides support in performing equipment, facility and utility qualification activity and requalification activity to ensure compliance to our quality requirements. Assist in the preparation/ execution of Installation Qualification (IQ)/Operational Qualification (OQ)/Performance Qualification (PQ) protocols for equipment, facility and utilities as well as related software. Supports process validation and cleaning validation by providing product contact surface area, equipment qualification parameter ranges and challenge tests criteria to technical service. Conducts field execution of validation deliverables, resolve any deviations, and author reports. Assist in maintaining validation process improvement projects. Author/review/update appropriate SOP's. Follow Pharmaceutical industry standards in generating and updating supporting documentation such as P&IDs, material and equipment specifications, and requirement specifications. Work within cross-functional teams; communicates progress effectively to other team members and validation management. Ensure process and project documentation is accurate and updated. Maintains safe working environment. Ensures that all activities are in compliance with cGMP, Health Authority regulations and our policy. Support 3rd party validation activities, where applicable. Completes assigned validation projects in timely manner. Maintains and improves job knowledge by remaining current in industry trends, attending educational seminars, reading professional publications, participating in professional organizations. Maintain and update the Validation Master Plan (VMP) and ensure all validation documentation is accurate and complete. Support continuous improvement initiatives by analyzing process data and implementing corrective actions Performs other special projects and duties as assigned by department management. QUALIFICATIONS Candidates should have experience in qualification and process validation. Strong understanding of regulatory requirements and validation processes Demonstrated understanding reviewing/writing technical documents, risk assessment reports, Deviation/Investigation reports, CAPA, validation documents, IOQ/PQ protocols, and final reports. Bachelor's degree in Engineering or Science related field. 0 to 3 years of experience in pharmaceutical industries. Excellent problem-solving and communication skills. The ability to work successfully in both a team/matrix environment as well as independently. The ability to work in a fast-paced environment, manage priorities and maintain timelines for multiple projects. Ability to utilize Microsoft Word, Excel and Visio, Minitab, excellent word processing skills. Knowledge of Good documentation practices Ability to read, write, communicate, and handle stress produced by time pressure, customer demands, etc.

JOB PURPOSE: To design new devices/components and make design changes or improvements to existing devices/components. Leads major programs to bring new designs or design changes through the applicable phases of the Product Development Process. ESSENTIAL DUTIES: Functions as leader for major programs involving all phases of product design and development, leading Core Team through the execution of project activities Follows and improves the Product Development Process to ensure regulatory requirements are met and that the medical device meets the requirements for its intended use Plans and drives execution of project activities through the applicable project phases to the final phase of Commercial Release for ongoing production Applies the Risk Management Policy to the development process for identifying hazards, estimating and evaluating associated risks, controlling these risks and monitoring the effectiveness of risk controls Guides the project team through use of design and technology to drive innovation and significantly improve patient outcome Strives for improvement to ensure all applicable aspects of product design including design for manufacturability, scalability, testing, variability, and usability Diligently develops product requirements and design inputs based on the applicable standards as well as other relevant sources, such as Post-Market Surveillance Oversees creation of detailed sub-assembly and final assembly drawings to serve as design specifications for a medical device Develops verification and validation plans for the protocols, test methods, and reports for execution of design verification and validation testing Able to navigate completely new medical devices through product requirements, design inputs, design outputs, and verification/validation in traceability matrix Introduces design mitigations to significantly reduce the risk profile for the medical device as documented in Risk Management File, dFMEA, and pFMEA (design/process Failure Mode Effects Analysis) Evaluates and designs products, parts, or processes for cost efficiency to minimize the cost for patient care Coordinates project activities for Commercial Release of expansive product lines and corresponding manufacturing processes while meeting expectations for sustainable, efficient, repeatable, and reproducible manufacturing operations Leads Core Team to ensure that project phases are completed in a timely manner Defines activities for project execution to meet the requirements of the Product Development Process Supports request for quotes, specifically complex devices that vary greatly from predicates Upholds Spectrum Plastics Group vision and core values Follows all safety guidelines and adheres to safety absolutes QUALIFICATIONS (Education/Experience/Knowledge, Skills & Abilities) Required: Bachelor's degree in engineering or equivalent experience in a related field. 7+ years industry experience Proficient in commonly-used concepts, practices, and procedures within medical device design and development Experience as project manager on a project which involved all phases of product design and development, leading Core Team through the execution of project activities Knowledge on developing full-scale project plans Effectively communicated project expectations to team members and stakeholders in a timely and clear fashion Experience planning and driving execution of project activities through the applicable project phases to the final phase of Commercial Release for ongoing production Can handle financial responsibilities for major programs, such as budget accountability and revenue recognition Demonstrated history to problem solve, identify errors and deficiencies and perform research High degree of understanding of ISO 13485 requirements for Design Controls Ability to apply knowledge to their job function using pre-established guidelines and instructions Accuracy, attention to detail, and thoroughness Proficient computer skills Proficient communications skills Ability to comprehend and comply with company safety and quality standards Ability to provide oral and written instructions to others Preferred: Master's Degree in Engineering discipline Proficiency in Microsoft Project Demonstrated ability to complete product design transfers Knowledge of applicable standards for EtO sterilization (e.g. ANSI/AAMI/ISO 11135-1, ANSI/AAMI/ISO 11135-2) WORKING CONDITIONS: Works with minimal supervision from manager. Requires light physical activity performing non-strenuous daily activities NOTE: This job description is not intended to be an exhaustive list of all possible duties, responsibilities and or qualifications. Other duties, responsibilities and/or qualifications may be assigned to this position.

Job Title: Engineer II Duration: 12 Months Qualifications: Education: Bachelors in Science, Engineering or related field. Can be a mix of Co-op and real world experience (3-5+ years). Has experience in authoring design control documentations per 21 CFR 820.30 or device risk document per ISO 14971. Demonstrated interpersonal skills including flexibility and ability to work in a team environment. Proven analytical abilities. Work requires experience in engineering change assessment, root cause investigations and device risk document management. The candidate will work with a small team that supports life-cycle management activities of medical device combination products. Demonstrated interpersonal skills including flexibility and ability to work in a team environment. Proven problem solving abilities. Demonstrated written and verbal communication skills. Preferred skillsets- Medical device combination product background/experience, understanding root cause, deviation management and change management. Responsibilities: The basic function of this position is to author technical change assessment related to medical devices and to provide support to customer complaints - including ensuring the root cause appropriately considers the device and device constituents, author technical and risk assessment related to the device design change, and document the device risk analysis from complaints. Team supports multiple Medical Device and Combination Products (MDCP), such as vaccine prefilled syringes and devices. Comments/Special Instructions Perfect Candidate has more life cycle management activity experience (change control, technical writing, etc) not research. Small project management skills, good communication, technical writing. Medical device background/experience, understanding root cause, deviation management and change management. Hiring Manager Expectations: Specifically, I am looking for professionals who have hands-on experience with technical aspects such as authoring design verification documents and participating actively in lifecycle management, including the creation and management of Design Traceability Matrices, Verification and Validation Matrices, and Design History Files/Global Design Files. These skills are critical for the role and are not prominently featured in the resumes I've reviewed thus far. Additionally, I am looking for a candidate who has experience with commercialized products.

We are seeking a skilled Automation Engineer to join our team. This role focuses on building and maintaining automation solutions within Palantir Foundry, specifically around ontology-based tooling and networking data related to security. Key Responsibilities: Develop and maintain automation solutions in Palantir Foundry. Implement ontology-based tooling and functionalities in Foundry, such as Workshop and Vertex. Manage data pipelines and code repositories in Foundry. Develop automation scripts and applications using TypeScript for Foundry and Python for Apache Airflow. Collaborate with security teams on networking data. Utilize Apache Airflow for workflow automation. Troubleshoot and resolve technical issues. Communicate effectively with team members and stakeholders. Required Skills and Qualifications: Experience in automation engineering or data engineering. Proficiency in Palantir Foundry. Knowledge of ontology-based tooling (preferred but not required). Proficiency in TypeScript for Foundry code repositories and ontology functions. Proficiency in Python for Apache Airflow. Strong problem-solving and analytical skills. Excellent communication and teamwork abilities. Additional Skills and Qualifications: Understanding of networking data and security principles. Experience with data integration and ETL tools. Knowledge of Azure cloud platform. Familiarity with version control systems (e.g., Git). Experience with Palantir AIP and generative AI (valuable but not required). Experience with Snowflake (low priority). Some additional notes: Work ethic and ability to hit the ground running. How to model a Digital Twin Scripting automation and define ontology. What is the lab network from an ontology perspective? Foundry is rare skill set, not many have that AND ontology knowledge (tell me something cool you built is an interview question) No degree requirement Python and Apache Airflow.

100% Onsite at Warren NJ. Job ID# 82207 Rate type: W2 only The LSM Equipment Engineer supports the successful operation of laboratory and clinical manufacturing operations at their home sites through interaction with internal team members and internal customers, and external service providers. The incumbent conducts tasks assigned by the management independently or with minimum supervision. The LSM Equipment Engineer is responsible for initiating and owning deviations, CAPAs, and change controls, and authoring calibration and maintenance SOPs as well as performing calibrations, maintenance, and qualifications/validations. 2. REQUIRED COMPETENCIES: • Knowledge of cGMP, GXP, GAMP, including 21CFR part 11, computer systems validation requirements and good documentation practices. • Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment. • Knowledge of calibration management and environmental monitoring systems. • Strong critical thinking skills and the ability to work independently. • Excellent interpersonal and communication skills with experience dealing with a diverse workforce where individual initiative, accountability to the team, and professional maturity are required. • Strong multitasking and organizational ability. Ability to effectively manage multiple tasks and activities simultaneously. • Proficiency in Microsoft Office Suite - Word, Excel, PowerPoint, and Outlook; innate ability to learn new software, such as corporate intranet and enterprise applications. • Working knowledge of scheduling software and systems, and inventory management systems, e.g., Blue Mountain RAM and/or Maximo Computerized Maintenance Management System (CMMS) preferred. • Ability to interact effectively with QC, Manufacturing, QA, and Engineering & Facilities groups. 3. DUTIES AND RESPONSIBILITIES Operational Activities • Executes equipment calibration, preventative maintenance, performance verification, troubleshooting and repair activities in laboratory and manufacturing areas, as required per current scheduling (CMMS) System. • Escorts and supervises vendors for calibration, preventative maintenance, performance verification and repair functions as required per current scheduling (CMMS) System. • Reviews and approves vendor executed calibration, maintenance, repair, and performance verification records for accuracy, and completeness. • Documents and populates calibration/maintenance information in WPT (Work Plan Template) or MDT (Measurement Data Template) using CMMS system. • Modifies or update CMMS documentation as required. • Prepares reports and keeps records on calibration inspection, testing, and repairs. • Executes requalification on Controlled Temperature Units (ex. Refrigerators, Freezers (which includes -20C / -80C Freezers), Incubators, Cryotanks, Cryopods, and Storage Rooms/Areas). • Supports multiple sites within Warren and Summit. • Supports clinical manufacturing on-call equipment troubleshooting activities during weekends as required. • Ensures all calibration, PM, and performance verification records are filed appropriately after approval. • Contacts supplier for quotation on external calibration/PM of the equipment and calibration standards • Initiates, participates, and assists in resolution of quality investigations. • Authors and supports the development, revision, and review of written Standard Operating Procedures (SOP) for calibration, preventive maintenance, and performance verification of instruments/equipment. • Supports the development, review and approval of calibration and maintenance plans in site CMMS system. • Supports the execution of process improvement studies, as required. • Adheres to written policies and procedures governing the LSM department activities and the equipment they manage to ensure compliance with approved standards. • Performs inventory of the equipment and/or standards in the labs as required. • Maintains a positive relationship with the site customers and outside vendors while promoting a positive team environment. • Participates actively in special projects as required. • Ensure low cost of the Laboratory Systems Management (LSM) department (Reducing overtime, implementing innovative ideas) • Plans, justify and implement cost reduction small projects. • Usage of several test equipment and tools (e.g., pressure gauges, temperature, humidity meters, flow meters, particle counters and temperature mapping equipment etc.) • Owns and supports deviations and investigations that result from calibration or performance verification activities, along with developing and supporting the implementation of corrective and preventive actions. • Support the development, review and approval of calibration and maintenance plans in site CMMS system. • Follows cGMP (current Good Manufacturing Practices) and ALCOA principles ('ALCOA' defines that data should be Attributable, Legible, Contemporaneous, Original, and Accurate) In addition, 'ALCOA+' guidance recommends that data is also Complete, Consistent, Enduring, and Available. Inventory Management • Work with Planning group to ensure system is updated as calibration, maintenance and performance verification activities are performed. • Approves Change Request, Asset Inductions, and Work Request. • Approving Calibration and Maintenance forms. • Perform NCRs investigations. • Review and approve calibration and maintenance work. Regulatory Responsibilities • Maintains all required Corporate, Facilities and EHS training as required. • Adheres to all safety procedures and hazard communication. • May be called upon to act as SME in both internal and regulatory audits. 4. EDUCATION AND EXPERIENCE • BS in Engineering or Science related discipline preferred. • Minimum 3 years of experience in FDA-regulated industry. • Minimum 3 years of experience working directly with laboratory equipment (ex. centrifuges, temperature/humidity meters, balances, freezers, refrigerators etc.) • Maintenance coordination / planning experience preferred. • Experience working in a clinical environment preferred.

As the Engineering Department Lead, you'll oversee system design and takeoffs for new opportunities, ensuring every project is executed with creativity and precision. In addition to managing the engineering team, you will also lead our BIM (Building Information Modeling) efforts, steering the successful execution of complex designs using AutoCAD and Revit. This role offers a unique opportunity to collaborate on some of the most exciting and innovative projects in the industry. Based in Maplewood, NJ, this position is perfect for someone with a strong technical background in AV systems and a passion for managing teams, solving problems, and pushing design boundaries. Key Responsibilities: Department Leadership: Oversee all design and engineering efforts across Mode:Green and Eclipse Design Group's projects. Streamline workflows for system design, drafting, and project execution. Collaborate with sales, project managers, and installation teams to align on project scopes. Design & Drafting: Engineer AV systems using AutoCAD and Revit, ensuring designs meet both clientexpectations and project specifications. Prepare detailed schematics, drawings, and layouts for high-end hospitality, corporate and entertainment projects. Provide accurate takeoffs and bills of materials for new opportunities. BIM Team Leadership: Lead and mentor the BIM team to create 3D models and technical documentation for technology integration. Ensure timely delivery of models and adherence to quality and industry standards. Promote continuous learning and improvement within the team. Collaboration & Client Engagement: Work closely with architects, designers, and consultants to integrate AV and technology seamlessly into overall project designs. Participate in client meetings, design charrettes, and site visits to refine project requirements. Serve as the technical resource and subject matter expert for AV system design. Anything else the company may require to contribute to the overall team's success. Qualifications Bachelor's degree in engineering, Technology, or a related field (or equivalent experience). At least 5+ years of experience in AV system design and engineering, with leadership experience preferred. Proficiency in AutoCAD and Revit for design and drafting. Expertise in AV systems, control systems, and technology integration for luxury and complex environments. Familiarity with BIM workflows and the ability to manage 3D modeling processes. Strong organizational, communication, and problem-solving skills. Mode:Green provides multiple employee benefits including Paid Time Off (vacation, personal etc.), paid holidays, medical plans, matching 401k.

We have an exciting opportunity for a client who is urgently hiring for a seasoned CSV Engineer who has direct experience implementing Veeva Quality System. If you enjoy implementing systems, using your CSV expertise to its full capacity, and engaging with stakeholders for key projects, let's set up a time to chat! Job Responsibilities: Establish Product Vision: Develop and maintain a clear, strategic product vision that aligns with both business objectives and customer needs. Ensure Quality Compliance: Apply knowledge of quality systems within the life sciences sector to ensure adherence to industry standards and regulations. Manage Product Backlog: Prioritize and manage the product backlog to ensure the most valuable and impactful features are delivered first. Collaborate with Stakeholders: Partner with key stakeholders to gather requirements, address their needs, and integrate feedback into the product development lifecycle. Guide Development Lifecycle: Oversee the product's journey from concept to release, ensuring all stages of development are efficiently executed. Create and Refine User Stories: Act as the bridge between the GPO and SMEs, translating business requirements into actionable, testable user stories. Define Acceptance Criteria: Set clear and concise acceptance criteria for each feature to ensure development teams understand what's required for success. Monitor Development Progress: Track product development progress to ensure timelines are met, and quality standards are upheld. Participate in Scrum Activities: Engage in Scrum meetings and sprints, providing progress updates, addressing blockers, and ensuring alignment with the overall product vision. Document and Report: Prepare and present user requirements and system documentation, ensuring clear communication of product needs. Develop Data Strategy: Design and implement a data strategy that supports the organization's immediate and long-term goals. Job Qualifications: Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related discipline. Minimum of 10 years of experience in Computer System Validation (CSV) within a regulated environment (preferably pharmaceutical, biotech, or medical device). Proven hands-on experience with the implementation of Veeva Systems. Deep understanding of GAMP 5 methodology and FDA 21 CFR Part 11 compliance. Proficient in developing and executing IQ/OQ/PQ protocols. Experience with laboratory workflows and integrating Empower with analytical instruments. Solid knowledge of change control, deviation management, and CAPA processes. Strong grasp of data integrity principles and their application within QMS systems. Exceptional written and verbal communication skills, with the ability to create documentation and conduct training. Highly detail-oriented, with strong organizational and problem-solving capabilities. Ability to work both independently and as part of a collaborative team.

Job Title: Senior Machine Learning Operations Engineer Workplace Type: Hybrid, 3 days per week (Holmdel, NJ) Index Engines is the world's leading AI-powered analytics engine to detect data corruption due to ransomware. The company's CyberSense product empowers organizations to detect ransomware and data corruption and facilitate rapid recovery from attacks. CyberSense is the last line of defense for thousands of organizations worldwide. Role Overview: Index Engines has an outstanding career opportunity for a senior-level Machine Learning (ML) Operations (Ops) Engineer. The ideal candidate will help us deploy, manage, and optimize our machine-learning models. Responsibilities: Manage ML Pipeline(s) Manage ML systems and operations: Ransomware acquisition pipeline operations, manage detonation and analysis services, manage recurring reports of new ransomware detonated images, some System Admin, and VM management. Manage Cloud services. Collect, analyze, and report on internally collected data Data acquisition/Web crawling Collaboration: Work closely with data engineers, software developers, and IT teams to ensure seamless integration of ML models. Provide technical leadership within assigned areas of responsibility. Requirements: Proven experience in deploying and managing machine learning models in production. Proficiency in programming languages such as Python. Familiar with pandas and numpy. Experience with shell scripting on Linux and Windows. Experience with VMware operations and administration. Excellent problem-solving and communication skills. Strong written and oral communication skills. Enjoys working in a challenging and highly collaborative environment. Able to accommodate time zone differences to work with teams in the US and Asia. Require minimal supervision and be able to operate in a matrixed organization. Bachelor's degree in computer science or related field. Minimum of 7-10 years of professional experience. Preferred: Knowledge of data engineering and data pipeline tools. Experience with SVN, git, Jira, and Confluence. Experience setting up and configuring PCs, Networks, and ESXi hosts. Why Join Index Engines? Opportunity to work with a pioneering, rapidly growing company in cybersecurity and backend storage solutions. Collaborative and innovative work environment. Competitive salary and benefits package.

We are hiring a mid or senior-level engineer with experience related to nuclear power plants. This person will work as a technical expert in thermos-hydraulics and fluid structural interactions. You will work with a dedicated business manager and a 40-year industry service base to grow the department and support an expected upturn in the industry. Successful candidates will have a solid technical background as well as strong interest in developing, marketing, and implementing innovations to support existing and new plants/customers. Prior experience in nuclear power generation is essential. A bachelor's degree in engineering or a related field with at least 10 years of experience working in nuclear power is desired. Less years of experience may be required for applicants with relevant advanced degrees (masters/PhD).

Job Description: Facilities Junior Engineer / Facilities Engineering Specialist / Facilities Support Specialist About Us Evergreen Theragnostics, Inc. is a radiopharmaceutical company headquartered in Springfield, NJ. We operate in a brand-new state-of-the-art facility, developing our own radiopharmaceutical products and providing contract development and manufacturing services for other radiopharmaceutical companies. We also operate our own cutting edge cancer research laboratories. Evergreen is a small team, where all team members support each other in a variety of activities. We are looking for team members who are motivated to take on new challenges. Job Summary: The “Facilities Support Specialist” will be responsible for the upkeep, repair, and improvement of our facility while supporting IT-related tasks, reporting into our Facilities Manager. This role requires a hands-on individual with a proactive approach to facility management and technical troubleshooting. The ideal candidate will have experience in general maintenance and basic knowledge of IT systems to assist with the day-to-day operations of our facility. Key Responsibilities: Perform routine inspections and maintenance of building systems, including Building Management Systems (BMS), HVAC, plumbing, electrical, fire safety and emergency power systems. Assist with IT-related tasks, including basic troubleshooting and maintenance of hardware issues Support the setup, maintenance, and repair of office technology, such as computers, printers, furniture and other IT related equipment Collaborate with the Facilities Management and IT to ensure seamless integration of facilities and IT systems. Manage work orders, prioritize tasks, and ensure timely completion of all maintenance requests. Assist with external vendors for specialized equipment calibration and maintenance services. Maintain accurate records of maintenance activities, supplies, and inventory. Ensure compliance with safety regulations and company policies. Qualifications: High school diploma or equivalent; technical certifications in facilities maintenance or IT systems are a plus. Bachelor's degree in a related field (engineering) is encouraged but not required. 2+ years of experience in facilities maintenance, with experience in IT systems support preferred. Basic understanding of IT infrastructure, including network cabling, hardware troubleshooting, and software installations is preferred. Strong problem-solving skills with a hands-on approach to both maintenance and IT challenges. Ability to work independently, prioritize tasks, and manage time effectively with Excellent communication skills. Willingness to be on call for emergencies and to work flexible hours as needed.

Title - Equipment Engineer Months- 12+ Months (potential extension) Pay Range- $50-53/hr. 2. REQUIRED COMPETENCIES: • Knowledge of cGMP, GXP, GAMP, including 21CFR part 11, computer systems validation requirements and good documentation practices. • Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment. • Knowledge of calibration management and environmental monitoring systems. • Strong critical thinking skills and the ability to work independently. • Excellent interpersonal and communication skills with experience dealing with a diverse workforce where individual initiative, accountability to the team, and professional maturity are required. • Strong multi‐tasking and organizational ability. Ability to effectively manage multiple tasks and activities simultaneously. • Proficiency in Microsoft Office Suite - Word, Excel, PowerPoint, and Outlook; innate ability to learn new software, such as corporate intranet and enterprise applications. • Working knowledge of scheduling software and systems, and inventory management systems, e.g., Blue Mountain RAM and/or Maximo Computerized Maintenance Management System (CMMS) preferred. • Ability to interact effectively with QC, Manufacturing, QA, and Engineering & Facilities groups. 3. DUTIES AND RESPONSIBILITIES Operational Activities • Executes equipment calibration, preventative maintenance, performance verification, troubleshooting and repair activities in laboratory and manufacturing areas, as required per current scheduling (CMMS) System. • Escorts and supervises vendors for calibration, preventative maintenance, performance verification and repair functions as required per current scheduling (CMMS) System. • Reviews and approves vendor executed calibration, maintenance, repair, and performance verification records for accuracy, and completeness. • Documents and populates calibration/maintenance information in WPT (Work Plan Template) or MDT (Measurement Data Template) using CMMS system. • Modifies or update CMMS documentation as required. • Prepares reports and keeps records on calibration inspection, testing, and repairs. • Executes requalification on Controlled Temperature Units (ex. Refrigerators, Freezers (which includes -20°C / -80°C Freezers), Incubators, Cryotanks, Cryopods, and Storage Rooms/Areas). • Supports multiple sites within Warren and Summit. • Supports clinical manufacturing on-call equipment troubleshooting activities during weekends as required. • Ensures all calibration, PM, and performance verification records are filed appropriately after approval. • Contacts supplier for quotation on external calibration/PM of the equipment and calibration standards • Initiates, participates, and assists in resolution of quality investigations. • Authors and supports the development, revision, and review of written Standard Operating Procedures (SOP) for calibration, preventive maintenance, and performance verification of instruments/equipment. • Supports the development, review and approval of calibration and maintenance plans in site CMMS system. • Supports the execution of process improvement studies, as required. • Adheres to written policies and procedures governing the LSM department activities and the equipment they manage to ensure compliance with approved standards. • Performs inventory of the equipment and/or standards in the labs as required. • Maintains a positive relationship with the site customers and outside vendors while promoting a positive team environment. • Participates actively in special projects as required. • Ensure low cost of the Laboratory Systems Management (LSM) department (Reducing overtime, implementing innovative ideas) • Plans, justify and implement cost reduction small projects. • Usage of several test equipment and tools (e.g., pressure gauges, temperature, humidity meters, flow meters, particle counters and temperature mapping equipment etc.) • Owns and supports deviations and investigations that result from calibration or performance verification activities, along with developing and supporting the implementation of corrective and preventive actions. • Support the development, review and approval of calibration and maintenance plans in site CMMS system. • Follows cGMP (current Good Manufacturing Practices) and ALCOA principles ('ALCOA' defines that data should be Attributable, Legible, Contemporaneous, Original, and Accurate) In addition, 'ALCOA+' guidance recommends that data is also Complete, Consistent, Enduring, and Available. Inventory Management • Work with Planning group to ensure system is updated as calibration, maintenance and performance verification activities are performed. • Approves Change Request, Asset Inductions, and Work Request. • Approving Calibration and Maintenance forms. • Perform NCR's investigations. • Review and approve calibration and maintenance work. Regulatory Responsibilities • Maintains all required Corporate, Facilities and EHS training as required. • Adheres to all safety procedures and hazard communication. • May be called upon to act as SME in both internal and regulatory audits. 4. EDUCATION AND EXPERIENCE • BS in Engineering or Science related discipline preferred. • Minimum 3 years of experience in FDA-regulated industry. • Minimum 3 years of experience working directly with laboratory equipment (ex. centrifuges, temperature/humidity meters, balances, freezers, refrigerators etc.) • Maintenance coordination / planning experience preferred. • Experience working in a clinical environment preferred. Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit ******************* to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status

Responsibilities / Skills Must have: Highly Experienced with Azure Databricks features Deal with some of the Ambiguities in the codebase Experienced with coding in Python, Pyspark Must have experience with cluster configurations Proficiency in Databricks and Azure Cloud, Databricks Asset Bundles, Hoslistic vision on the Data Strategy. Proficiency in Data Streaming and Data Modeling Strong understanding of data scaling and its complexities Data Archiving and Purging mechanisms Experienced with Sql Good problem solver Should have experience mentoring team members.

We are hiring for Senior Power-BI Engineer for our insurance client. Title : Senior Power-BI / Analytics Engineer Required Skills : Power BI, Analytics, Data Fabric & Azure /ADF Domain : Property & Casualty (P&C) insurance is a huge plus but not mandatory Please email me your resume at ******************************* Overview of the Position The Power-BI / Analytics Engineers will be responsible for building, maintaining and optimizing the data pipelines and infrastructure that power our Analytical capabilities. They will collaborate closely with data scientists, data analysts, and data engineers to ensure the reliable delivery of high-quality data to enable data driven business decisions for our company. Focus on build and maintain analysis-ready data infrastructure Creating reporting/visualizations that drive actionable insights Strong understanding of the Property & Casualty (P&C) business, key metrics and KPIs (this is highly desired and a big plus, but not a MUST-have) Strong proficiency in SQL and experience with relational databases and data warehousing concepts Experience with ETL/ELT tools (Azure ADF) and other Azure Cloud technologies (Data Fabric) Strong experience with BI tools like Power BI for data visualization and dashboard creation Data Pipeline Development and Maintenance Design, build, and maintain robust and scalable data pipelines for ingesting, transforming, and storing data from various sources (e.g., policy administration systems, claims systems, third-party data providers) Implement and optimize ETL/ELT processes using modern data engineering tools and technologies (e.g., Azure ADF, cloud-based data warehouses like Azure Fabric). Data Reporting and Visualization Create clear, concise and visually appealing dashboards and reports using Power BI Maintain and Optimize Power BI reports, dashboards, and other data presentation products that align to the enterprise architecture Thanks and Regards, Ankit Grover Sr. Executive - TA Iris Software 200 Metroplex Drive, Suite #300, Edison, NJ 08817 Email : ******************************* ********************