Validation Engineer - San Diego - Staftonic LLC

    Staftonic LLC
    Staftonic LLC San Diego

    16 hours ago

    Pharmaceutical / Bio-tech
    Description

    Validation Engineer

    Location: San Diego, California

    Long-Term Project

    Key Responsibilities

    • Author, review, and execute validation protocols (IQ, OQ, PQ)
    • Support process, equipment, cleaning, and facility validation activities
    • Maintain validation lifecycle documentation and ensure audit readiness
    • Support requalification and periodic review activities
    • Work with Quality, Engineering, Manufacturing, and external vendors
    • Investigate deviations and support CAPA and change control activities
    • Ensure compliance with GMP, FDA, and regulatory standards

    Required Experience

    • Experience in pharmaceutical, biotech, or medical device industry
    • Hands-on validation experience in GMP environment
    • Experience with equipment qualification (IQ/OQ/PQ)
    • Strong protocol writing and execution experience
    • Knowledge of validation lifecycle documentation

    Preferred Experience

    • Cleaning validation experience
    • Facility/utility/cleanroom qualification
    • Computer System Validation (CSV/CSA) exposure
    • Experience with validation or QMS systems (Kneat, Veeva, TrackWise, etc.)

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