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Engineer, QA Validation/ Validation Engineer (QA/GMP)
Engineer, QA Validation/ Validation Engineer (QA/GMP)Tap Growth ai • Novato, California, US
Engineer, QA Validation / Validation Engineer (QA / GMP)

Engineer, QA Validation / Validation Engineer (QA / GMP)

Tap Growth ai • Novato, California, US
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🌟 We're Hiring : Engineer, QA Validation! 🌟

We are seeking to hire an Engineer, QA Validation in Novato, CA.

📍 Location : Novato, United States

⏰ Work Mode : Work From Office

💼 Role : Engineer, QA Validation

Pay Scale :   $85, 363 - $106, 716 (Dependent on Experience)

What You'll Do :

  • Review and approve user requirement specifications, automation functional requirement

specifications and software design documentation for automated facility, utility and equipment.

  • Review and approve FAT’s, SAT’s, Commissioning and Automation Acceptance Testing,
  • qualification (IQ, OQ & PQ) protocols, validation discrepancy reports and final report packages of

    Facilities, Utilities and Equipment to support implementation of new systems, changes, revalidation

    and periodic review of existing systems.

  • Experience with implementation of data integrity in a GMP environment.
  • Define and document the data life cycle for GMP systems.
  • Perform Data Integrity Risk Assessment and develop mitigation strategies to address risks.
  • What We're Looking For :

  • BS in a technical discipline (Engineering, physical or biological sciences) / Equivalent experience
  • may be considered.

  • Training in project management is preferred.
  • 5+ years’ experience in a GMP regulated environment (Biotech or equivalent), with  exhibited knowledge or proficiency in engineering.
  • Experience in the review and approval of Validation and Qualification lifecycle documentation
  • such as URS, IQ / OQ / PQ, Commissioning and Automation testing documentation.

    Ready to ensure excellence? 🚀 Apply now and let's build quality together!

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    Validation Engineer • Novato, California, US

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