Validation Engineer II Jobs in Boston, MA

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Equipment Validation Engineer II

Katalyst Healthcares and Lifesciences

•

Boston, Massachusetts, USA

Full-time

Responsibilities: Authoring and/or reviewing of SOP's (both new and existing). Authoring and/or reviewing Equipment Requirements Specifications. Document calibration and maintenance requirements, generate procedures. Supporting Equipment Management Program. Schedule and work with suppliers to perform service, installation, calibration, maintenance activities for facility, utilities, and equipment. Troubleshoot manufacturing issues to identify root causes and implement corrective actions.
Posted 20 days ago | Updated 1 hour ago

Validation Support Engineer

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
Posted 4 days ago | Updated 1 hour ago

Validation Engineer III

Katalyst Healthcares and Lifesciences

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Waltham, Massachusetts, USA

Full-time

Responsibilities: Local Validation Program Maintenance. QAV Documentation Review and Approvals for local and CMO's. CS Periodic Reviews planning and approvals. QA GMP IT Support for DI and CS INF activities. Validation and Metrology QMS events ownership as QAV (Change Control, CAPA & Deviation). QRFR's Generation. Metrology Deliverables Review & Approval (forms or SOP's) + SAP Operation. SME support on the GMP Equipment Calibration/ PM/ Breakdown assessment from QAV Technical perspective. V
Posted 20 days ago | Updated 1 hour ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Framingham, Massachusetts, USA

Full-time

Responsibilities: Execute validation activities in computerized system and ensure 21 CFR part 11 compliance. Knowledge in GAMP. Preparing trace matrix to ensure requirements are tested to meet the software intended use. Preparing risk assessment for functional requirements and providing testing. strategy, implementing technical & procedural controls as part of mitigation. Preparing SOP/Work instruction for equipment and software-based systems. Requirements: 6 to 8 years of Non-Product Software
Posted 20 days ago | Updated 1 hour ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Raynham, Massachusetts, USA

Full-time

Responsibilities: Ask candidates if they have validated equipment and what type of equipment they have validated. Mechanical/manufacturing experience. Writing and executing validation protocols. CSV is nice to have, but if the candidate has done that exclusively it will not work. Requirements: A minimum of a Bachelor's degree in Engineering is required. Minimum of 1-3 years' experience in medical device manufacturing, Bio/pharma is also good Develop and implement processes to support the
Posted 20 days ago | Updated 1 hour ago

Verification and Validation R&D Engineer

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
Posted 20 days ago | Updated 1 hour ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Waltham, Massachusetts, USA

Full-time

Responsibilities: Independently perform validation activities including installation qualification, operational qualification, performance qualification for Base Camp projects related to facility, utilities, equipment and instrument. Generate protocols for tests, verification, and qualification for GxP assets, as well as reports to document execution. Ensure deliverables meet the overall facility milestones. Perform and support periodic assessment review and revalidation activities. Ensure deliv
Posted 20 days ago | Updated 1 hour ago

Validation Engineer, Sterile & Cleaning

Katalyst Healthcares and Lifesciences

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Bedford, Massachusetts, USA

Full-time

Responsibilities: We are seeking an experienced Sterile & Cleaning Validation Engineer to support validation activities within a medical device manufacturing environment. The ideal candidate will have hands-on experience with sterile and cleaning validation processes, strong technical writing skills, and the ability to execute validation protocols independently. This role involves performing revalidation tasks for equipment and working closely with cross-functional teams. Develop and execute
Posted 20 days ago | Updated 1 hour ago

Process Validation Engineer

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
Posted 20 days ago | Updated 1 hour ago

Lead Engineer, Quality Validation

Katalyst Healthcares and Lifesciences

•

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
Posted 20 days ago | Updated 1 hour ago

Validation Engineer 2

Merck KgaA

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Bedford, Massachusetts, USA

Full-time

Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious mind
Posted 55 days ago | Updated 1 hour ago

Principal Engineer, Hardware & Silicon Validation

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
Posted 4 days ago | Updated 1 hour ago

Verification Engineer & Validation R&D Engineer

Katalyst Healthcares and Lifesciences

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Raynham, Massachusetts, USA

Full-time

Responsibilities: Establish equipment requirements by working closely with product design team, suppliers and the multi-functional project team. lign the equipment specifications to reliability and quality requirements within the framework of new products development or management of legacy products. pply Analytical and quantitative problem-solving using methods including but not limited to Root Cause Analysis and Design of Experiments. Define Manufacturing Process Flow, Master Validation Plan f
Posted 20 days ago | Updated 1 hour ago

Validation Engineer with Ciena Routing & Switching - Middletown, NJ (Remote is also fine)-Telecom Industry Prefer

GLOBAL IT CON LLC

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Remote or Middletown Township, New Jersey, USA

Contract

Job Title: Validation Engineer Job Location: Middletown, NJ (Remote is also fine) Job Duration:12 months Job Description: This position allows you to assist customers in optimally crafting, deploying, operating, and continuously improving cost-effective solutions based on a Service-Aware Operating System (SAOS) based Routing & Switching portfolio (RSP) and its associated network management platform. This is an on-customer premise technical role with a focus on facilitating customers to understan
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Posted 35 days ago | Updated 9 hours ago

Computer System Validation Engineer

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
Posted 20 days ago | Updated 1 hour ago

Engineer III, Validation

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
Posted 7 days ago | Updated 1 hour ago

Validation SME

HCL America Inc.

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Waltham, Massachusetts, USA

Full-time

We are HCLTech, one of the fastest-growing large tech companies in the world and home to 219,000 people across 60 countries, supercharging progress through industry-leading capabilities centered around Digital, Engineering and Cloud. ( ) The driving force behind that work, our people, are diverse, creative, and passionate, raising the bar for excellence on a regular basis. We, in turn, work hard to bring out the best in them as we strive to help them find their spark and become the best version
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Posted 6 days ago

FMS Verification & Validation Engineer- Aerospace Industry

DBSI Services

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Remote or Cedar Rapids, Iowa, USA

Full-time

Benefits: 401(k) 401(k) matching Relocation bonus Position: FMS Verification & Validation Engineer Location: Remote About the Role: We are seeking a skilled Verification Engineer with expertise in Flight Management Systems (FMS) The ideal candidate will have experience in verification and validation (V&V) processes for avionics systems, with a strong background in display, navigation, and application systems within FMS Skill Matrix: Yrs. In Flight Management Systems Yrs. In verification and v
Posted 60+ days ago | Updated 1 hour ago

RTL Validation Engineer

Millennium Global Technologies

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Remote

Contract, Third Party

Position: RTL Validation Engineer Location: Dallas, TX ( Remote) Duration: 6 months Visa Preference: GC s, EAD s, L2 EAD s RTL Validation, working knowledge of PCIE/CXL protocols. Familiarity with simulation technologies.Exceptional analytical skills and problem solving skills.Experience in crafting testbenches, methodologies for large and complex chips.Deep understanding of verification concepts.Proficiency with at least one of these - C++, Object Oriented Programming, UVM, System Verilog.Fam
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Posted 1 day ago

Principal Process Controls & Validation Engineer

Regeneron Pharmaceutical

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Remote or Rensselaer, New York, USA

Full-time

Regeneron is currently looking for a Principal/ Staff Process Controls & Validation Engineer for the Labeled Drug Product fill/finish manufacturing processes. This is Monday-Friday, 8am-4:30pm schedule. Process Sciences is a technical services department that deals with a range of scientific, technical, engineering, and mathematical needs from the laboratory to the manufacturing floor. This role provides technical support to manufacturing, quality and CMC Regulatory for manufacturing processes f
Posted 31 days ago | Updated 1 hour ago