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Engineering Jobs

Validation Engineer

Karwell Technologies

  • San Jose, CA
  • 30+ days ago

    Highlights

    In this position, you will be responsible for the planning, execution, and documentation of validation protocols (IQ/OQ/PQ) for medical device manufacturing processes and equipment. Familiarity with FDA 21 CFR Part 820, ISO 13485, and Good Manufacturing Practices (GMP).

    Numbers & Facts

    LocationSan Jose, CA

    Description

    Summary:
    In this position, you will be responsible for the planning, execution, and documentation of validation protocols (IQ/OQ/PQ) for medical device manufacturing processes and equipment. You will work cross-functionally to ensure the products meet the highest quality standards.

    Roles & Responsibilities:
    • Develop and execute validation plans and reports.
    • Analyze data and troubleshoot process deviations.
    • Ensure compliance with FDA regulations and ISO standards.
    • Collaborate with Engineering and Quality teams to drive continuous improvement.
    Required Qualifications:
    • 8+ years of validation experience in the medical device or other regulated industry.
    • Strong expertise in injection molding and plastic materials.
    • Hands-on experience with cleaning validation and contamination control.
    • Solid understanding of the validation lifecycle (IQ/OQ/PQ) and statistical analysis.
    • Familiarity with FDA 21 CFR Part 820, ISO 13485, and Good Manufacturing Practices (GMP).

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