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Validation Specialist

Karwell Technologies

  • Framingham, MA
  • 30+ days ago

    Highlights

    Roles & Responsibilities: Support cleaning validation activities, protocol execution, sampling, and documentation. Support validation lifecycle activities, change controls, investigations, and CAPAs.

    Numbers & Facts

    LocationFramingham, MA

    Description

    Roles & Responsibilities:
    • Support cleaning validation activities, protocol execution, sampling, and documentation.
    • Perform temperature mapping and requalification of controlled temperature units.
    • Execute IQ/OQ/PQ, requalification, and periodic review for GMP equipment and utilities.
    • Support commissioning, installation, and qualification of new or modified equipment.
    • Assist with equipment troubleshooting alongside Engineering and Operations.
    • Generate validation documentation following cGMP, GDP, and SOP requirements.
    • Support validation lifecycle activities, change controls, investigations, and CAPAs.
    • Participate in audit readiness and regulatory inspection support.
    • Bachelor's degree in Engineering, Life Sciences, or related discipline required.
    • 5+ years of hands-on validation experience with GMP equipment and utilities.

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