Process Validation Engineer Jobs in Massachusetts

1 - 20 of 26 Jobs

Process Validation EngineerJob Title - Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Danvers, Massachusetts, USA

Full-time

Roles & Responsibilities: Process Validation (IQ/OQ/PQ). Product development experience. Process development. Process Layout, Modeling, and Documentation. Equipment and Tooling Development. Process Development and Characterization. Test Method Development and Validation. Developing / Updating MPIs. Supplier Development and Component Engineering. Manufacturing Engineering Support / Engineering Documentation. Update work instructions to match the practice on the floor to what's in the p

Computer System Validation (CSV) EngineerJob Title - Computer System Validation (CSV) Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. Author and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's

Associate Manager, Data Validation EngineerJob Title - Associate Manager, Data Validation Engineer

Takeda pharmaceuticalCompany Name - Takeda pharmaceutical

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Boston, Massachusetts, USA

Full-time

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by

Validation Support EngineerJob Title - Validation Support Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Boston, Massachusetts, USA

Full-time

Job Description: We are seeking an experienced Validation Support Engineer to lead validation activities for Beckhoff Twin CAT PLC-controlled systems in a 24/7 GMP-regulated manufacturing environment. The role focuses on ensuring compliance with FDA regulations (21 CFR Part 11, 210, 211, 820), GAMP5 methodologies, and internal quality standards. Responsibilities: Develop/update Validation Plans (VP) and Master Validation Plans (MVP). Lead GxP risk assessments for system changes. Author and

Principal Validation EngineerJob Title - Principal Validation Engineer

Johnson & JohnsonCompany Name - Johnson & Johnson

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Danvers, Massachusetts, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m

Computer System Validation EngineerJob Title - Computer System Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles. Compliance Analysis, Validation Planning, Risk Assessments Test planning and strategy creation and execution of test protocols, scripts and reports. V

Engineer III, ValidationJob Title - Engineer III, Validation

Thermo Fisher ScientificCompany Name - Thermo Fisher Scientific

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Remote or Fair Lawn, New Jersey, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description When you're part of Thermo Fisher Scientific, you'll do meaningful work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the

Verification and Validation R&D EngineerJob Title - Verification and Validation R&D Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Marlborough, Massachusetts, USA

Full-time

Responsibilities: Designs, develops, and implements cost-effective methods of testing and troubleshooting systems and equipment. Prepares test and diagnostic plans/programs and infrastructure, designs test fixtures and equipment, and completes specifications and procedures for new products. Plans the labor, schedules, and equipment required for testing and evaluating standard and special devices. Lead and execute Verification and Validation (V&V) activities for disposable kit development. De

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Norwood, Massachusetts, USA

Full-time

Job Description: The purpose of the Validation Engineer (contract position) is to complete assignments in support of Quality and Engineering for equipment qualification, new product development, process validation and test method validation. The successful candidate will assume responsibility for drafting qualification protocols, qualification reports and engineering study reports, along with data analysis and an intermediate level of experience in the use of statistics. This position will also

Electrical Validation EngineerJob Title - Electrical Validation Engineer

Steck SystemsCompany Name - Steck Systems

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Remote

Contract, Third Party

Job: Senior Electrical/Systems Test Engineer What the job involves We are seeking an Electrical/Systems Test Engineer to join our team. In this role, you will play a critical part in the testing and validation of our hardware systems. You will work on Electrical/system testing, validation, and hardware debugging of electrical components and systems involving edge processors, cameras and Linux environment. Responsibilities You will be responsible for system-level testing & debugging, and hardware

Sr. Test & Validation Engineer, ITASJob Title - Sr. Test & Validation Engineer, ITAS

RTX CorporationCompany Name - RTX Corporation

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Andover, Massachusetts, USA

Full-time

Date Posted: 2025-07-18 Country: United States of America Location: MA101: Andover MA 350 Lowell St Essex 350 Lowell Street Essex, Andover, MA, 01810 USA Position Role Type: Onsite U.S. Citizen, U.S. Person, or Immigration Status Requirements: Active and transferable U.S. government issued security clearance is required prior to start date.Security Clearance: DoD Clearance: Secret At Raytheon, the foundation of everything we do is rooted in our values and a higher calling - to help our nation

Senior Commissioning, Qualification & Validation (CQV) EngineerJob Title - Senior Commissioning, Qualification & Validation (CQV) Engineer

Johnson & JohnsonCompany Name - Johnson & Johnson

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Remote or Athens, Georgia, USA

Full-time

Senior Validation EngineerJob Title - Senior Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Lexington, Massachusetts, USA

Full-time

Responsibilities: Shire Human Genetic Therapies Inc. is seeking a Senior Validation Engineer with the following duties: Write Validation documents per Food Drug Administration (FDA)/Company guidelines; draft Specification documents and Validation Plans (VPs) for pharmaceutical manufacturing and laboratory equipment; Write and execute qualification protocols for new equipment and decommissioning protocols for old equipment. Execute approved protocols per company Good Documentation Practices (cG

Senior Validation EngineerJob Title - Senior Validation Engineer

Takeda pharmaceuticalCompany Name - Takeda pharmaceutical

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Lexington, Massachusetts, USA

Full-time

Engineer III, ValidationJob Title - Engineer III, Validation

Thermo Fisher ScientificCompany Name - Thermo Fisher Scientific

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Remote or Waltham, Massachusetts, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific Inc. LOCATION: 168 Third Avenue, Waltham, MA 02451 TITLE: Engineer , Validation HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Perform technical diagnosis of operational problems, repairs, and calibrations on a wide range of laboratory equipment to ensure that the equipment is operating to the customer's complete satisfaction and manufacture specifications; Perform techn

Test & Validation Engineer IIJob Title - Test & Validation Engineer II

RTX CorporationCompany Name - RTX Corporation

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Westford, Massachusetts, USA

Full-time

Date Posted: 2025-06-24 Country: United States of America Location: HMA03: ISR Systems - Westford HO 7 Technology Park Drive, Westford, MA, 01886 USA Position Role Type: Onsite U.S. Citizen, U.S. Person, or Immigration Status Requirements: The ability to obtain and maintain a U.S. government issued security clearance is required.Security Clearance: DoD Clearance: Secret At Raytheon, the foundation of everything we do is rooted in our values and a higher calling - to help our nation and allies

Sr. Test & Validation EngineerJob Title - Sr. Test & Validation Engineer

RTX CorporationCompany Name - RTX Corporation

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Andover, Massachusetts, USA

Full-time

Date Posted: 2025-06-18 Country: United States of America Location: MA101: Andover MA 350 Lowell St Essex 350 Lowell Street Essex, Andover, MA, 01810 USA Position Role Type: Onsite U.S. Citizen, U.S. Person, or Immigration Status Requirements: Active and transferable U.S. government issued security clearance is required prior to start date.Security Clearance: DoD Clearance: Secret At Raytheon, the foundation of everything we do is rooted in our values and a higher calling - to help our nation

Principal Engineer, Hardware & Silicon ValidationJob Title - Principal Engineer, Hardware & Silicon Validation

Marvell Semiconductor Inc.Company Name - Marvell Semiconductor Inc.

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Westborough, Massachusetts, USA

Full-time

About Marvell Marvell's semiconductor solutions are the essential building blocks of the data infrastructure that connects our world. Across enterprise, cloud and AI, automotive, and carrier architectures, our innovative technology is enabling new possibilities. At Marvell, you can affect the arc of individual lives, lift the trajectory of entire industries, and fuel the transformative potential of tomorrow. For those looking to make their mark on purposeful and enduring innovation, above and be

Lead Engineer, Quality ValidationJob Title - Lead Engineer, Quality Validation

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Andover, Massachusetts, USA

Full-time

Job Description: The contract Lead Engineer, Quality Validation will be responsible for providing quality and technical support for qualification and validation activities related to laboratory instruments, temperature control units and LFH/BSC units for internal customers. The individual will support and facilitate the review and approval of qualification/validation documentation for all stages of the equipment life cycle qualification process. Responsibilities: Provide quality oversight of Bl

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Fall River, Massachusetts, USA

Full-time

Job Description: The Validation Engineer is responsible for developing DQ/IQ/OQ/PQ protocols and coordinating and performing equipment qualifications, ensuring that automated process equipment that mass produce medical device consumables and other products, are designed, developed or changed in compliance with specifications, requirements, safety and Company and regulatory guidelines. The Validation Engineer will work closely with Senior validation staff, maintenance, operations, and R&D teams t