CQV Engineer

Karwell Technologies

  • Devens, MA
  • 30+ days ago

    Highlights

    This is a fast-paced opportunity focused purely on execution of validation protocols ideal for professionals who thrive on the manufacturing floor. We are looking for hands-on CQV Engineers to support a high-impact biologics project within a GMP-regulated environment.

    Numbers & Facts

    LocationDevens, MA

    Description

    Job Description:
    We are looking for hands-on CQV Engineers to support a high-impact biologics project within a GMP-regulated environment. This is a fast-paced opportunity focused purely on execution of validation protocols ideal for professionals who thrive on the manufacturing floor.

    Roles & Responsibilities:

    • Execute IQ/OQ protocols for process equipment.
    • Perform equipment walkdowns and verify against design.
    • Support SIP/CIP cycles, wet testing, and temperature mapping.
    • Work with downstream equipment (chromatography, filtration, tank farms, etc.).
    • Document and execute validation activities in ValGenesis.
    • Collaborate with QA/QC and Manufacturing teams.

    Requirements:

    • Strong experience in CQV / Validation (IQ/OQ).
    • Background in biologics / biopharma / cell culture.
    • Hands-on experience with process equipment validation.
    • Familiarity with GMP & GDP practices.
    • Experience with downstream equipment.

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