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CQV Engineer

Katalyst Healthcares & Life Sciences

  • Concord, NC
  • 11 days ago

    Highlights

    Autoclaves, Washers, Bioreactors, Mixers, Tanks & Vessels, CIP/SIP Systems, Process Skids, Filling Equipment, Packaging Equipment, Incubators, and Freezers. Seeking a CQV Validation Engineer experience in pharmaceutical, biotech, or life sciences.

    Numbers & Facts

    LocationConcord, NC

    Description

    Summary :
    Seeking a CQV Validation Engineer experience in pharmaceutical, biotech, or life sciences. The ideal candidate will have hands-on experience with Commissioning, Qualification & Validation (CQV) for standalone manufacturing equipment in a GMP-regulated environment.

    Roles & Responsibilities :
    • Perform CQV activities for standalone equipment.
    • Author and execute IQ/OQ/PQ protocols, validation plans, and reports.
    • Support FAT, SAT, commissioning, qualification, and validation activities.
    • Perform risk assessments and support deviations, CAPA, and change control.
    • Review vendor documentation, equipment manuals, and engineering drawings.
    • Ensure compliance with FDA, cGMP, GAMP 5, and 21 CFR Part 11.
    Education & Experience :
    • 5+ years of CQV validation experience in Pharma/Biotech.
    • Strong experience with standalone equipment qualification.
    • Hands-on experience with IQ/OQ/PQ protocol authoring and execution.
    • Knowledge of FDA, cGMP, GAMP 5, ISPE, and 21 CFR Part 11.
    • Preferred Equipment
    • Autoclaves, Washers, Bioreactors, Mixers, Tanks & Vessels, CIP/SIP Systems, Process Skids, Filling Equipment, Packaging Equipment, Incubators, and Freezers.

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