Validation Engineer

2 days ago

Boston MA, United States JMD Technologies Inc. Full time

Title: Validation Engineer Location: Boston Onsite, Leiden Center Duration: 6m+ There are 3 roles open here 2 beginner level (not entirely green but 1-2 yrs is fine) and 1 intermediate level (4+ yrs) KEY RESPONSIBILITIES: Draft and implement Quality System documentation designed to establish good validation practices within the organization. Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and internal quality standards. Support all stages of qualification of Analytical Instrument and Manufacturing equipment. Support all stages of qualification of automated manufacturing equipment Conduct Analytical Instrumentation Qualifications in accordance with USP and Vertex SOPs. Conduct Automation Assessments to ensure compliance with 21 CFR Part 11. Coordinate with vendor personnel to schedule and execute of test plans, if required. Coordinates with the internal stakeholders to safely and effectively schedule CQV activities, whenever required. Effectively works with cross departmental stakeholders, including but not limited to information services, EH&S, Global Security, design teams, and quality. Author documents related to or support process validation related activities that include but not limited to aseptic process simulations (APS), process performance qualification, material qualifications, etc. Develop cycles for sterilization processes and validate them, if required. Completes assigned training and ensures that they are 100% compliant 100% of the time. Ensure that all Validation activities align with the current SOPs, global standards and cGMP guidelines. Supports right-the-first time culture for all documents distributed across the organization. Ensure the Validation team reputation and partnership is flourished with the cross-functional teams. IDEAL CANDIDATES: Demonstrated ability to safely execute Validation activities in a dynamic fast paced environment. Experience developing and executing Validation protocols in a GMP Manufacturing and Analytical Laboratory areas. Receptive to change Adapts (quickly) to changing circumstances. Flexibility for off-shift hours, including weekend and night shift work. B.A, B.S. in Engineering or related discipline with 5-8 years of Validation experience or equivalent professional experience. Understanding and application of technical principles, theories, and concepts in the field, GMP, ISO, GAMP, ANSI.

  • Validation Engineer

    2 weeks ago

    Boston, MA, United States Ztek Consulting Full time

    Role: Qualification and Validation Analyst, on-site in Boston, MA / Indianapolis, IN - Full-time Locations: Boston, MA / Indianapolis, IN Job description: 381981- 380069/HE Must Have Technical/Functional Skills Experience Required: 3 - 10 + Years Experience in executing equipment validation, including IQ/PQ/OQ in a regulated environment Experience supporting...

  • Validation Engineer

    5 days ago

    Boston, United States JMD Technologies Inc. Full time

    Title: Validation Engineer Location: Boston Onsite, Leiden Center Duration: 6m+There are 3 roles open here – 2 beginner level (not entirely green but 1-2 yrs is fine) and 1 intermediate level (4+ yrs) KEY RESPONSIBILITIES:Draft and implement Quality System documentation designed to establish good validation practices within the organization.Author URS, IQ,...

  • Validation Engineer

    5 days ago

    Boston, United States JMD Technologies Inc. Full time

    Title: Validation Engineer Location: Boston Onsite, Leiden Center Duration: 6m+There are 3 roles open here – 2 beginner level (not entirely green but 1-2 yrs is fine) and 1 intermediate level (4+ yrs) KEY RESPONSIBILITIES:Draft and implement Quality System documentation designed to establish good validation practices within the organization.Author URS, IQ,...

  • Validation Engineer

    2 weeks ago

    Boston, United States JMD Technologies Inc. Full time

    ResponsibilitiesDraft and implement Quality System documentation designed to establish good validation practices within the organization.Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and internal quality standards.Support all stages of qualification of Analytical Instrument and Manufacturing equipment.Support all...

  • Senior Validation Engineer

    6 days ago

    Boston, Massachusetts, United States EPM Scientific Full time $120,000 - $150,000 per year

    Title: Senior Validation EngineerLocation: Boston, MA (on-site)About the Role:A growing biotech company working on regenerative medicine is looking for aSenior Validation Engineerto join their team. If you're experienced in GMP environments and enjoy hands-on work with equipment, processes, and documentation, this could be a great fit. You'll be helping make...

  • Validation Engineer

    5 days ago

    Boston, United States JMD Technologies Inc. Full time

    Execute aseptic process simulations (APS) and support process validation activities, including documentation, execution, and result review.Develop and author validation protocols such as URS, IQ, OQ, and PQ in alignment with GDP and GMP standards.Perform equipment and analytical instrument qualification following regulatory and internal guidelines.Conduct...

  • Sr. Validation Engineer

    2 days ago

    Cambridge, MA, United States EPM Scientific Full time

    Title: Senior Validation Engineer Location: Boston, MA (on-site) About the Role: A growing biotech company working on regenerative medicine is looking for a Senior Validation Engineer to join their team. If you're experienced in GMP biotech environments and enjoy hands-on work with equipment, processes, and documentation, this could be a great fit. What...

  • Validation Engineer x 3

    2 weeks ago

    Boston, United States The Autumn Group Full time

    Validation Engineer The Validation Engineer will report to the VCGT Validation leadership or an appropriate designee to execute Commissioning, Qualification and Validation activities. Key Responsibilities Draft and implement Quality System documentation designed to establish good validation practices within the organization. Author URS, IQ, OQ and PQ...

  • Project / Validation Engineer

    2 weeks ago

    Boston, United States Project Farma (PF) Full time

    IntroductionWelcome to the forefront of innovation in cutting edge patient treatments! We are thrilled to present an incredible opportunity to join our high performing organization. As a leader within the life science industry, we are constantly pushing the boundaries of what is possible and redefining the standards of excellence.Our dynamic team is composed...

  • Computer Systems Validation Engineer

    2 weeks ago

    Boston, United States Barry-Wehmiller Full time

    Description :Computer Systems Validation EngineerWho You’ll Work WithYou will join one of our 45 offices in the US, be part of a committed team of over 1500 professionals, and work in teams and directly with our clients doing work that is shaping the world around us. You will be welcomed into a rapidly growing business and team and empowered to make an...