Computer Systems Validation Engineer - Bloomingdale - Perspective Therapeutics, Inc.

    Perspective Therapeutics, Inc.
    Perspective Therapeutics, Inc. Bloomingdale

    4 days ago

    $114,000 - $164,000 (USD) per year
    Description

    Computer Systems Validation Engineer

    To execute all software validation activities for a brand-new start-up GMP-compliant Radioligand Therapy (RLT) pharmaceutical manufacturing facility, you will be responsible for ensuring that all software is designed, installed, tested and maintained in good compliance with global regulatory requirements.

    • Execute computer system validation start-up activities including production, quality, safety and facility software to support GMP radiopharmaceutical manufacturing.
    • Establish software specific standard operating procedures and workflows required to transition from start-up to steady-state manufacturing.
    • Maintenance & Calibration: Understand equipment and regulatory requirements to ensure the software properly supports their functions.
    • Ensure compliance with cGMP, FDA OSHA and other regulatory requirements through effective management of validation change controls CAPA deviation activities.

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