Validation Engineer

Karwell Technologies

  • Houston, TX
  • 30+ days ago

    Highlights

    Summary: We are looking for a Validation Engineer II with experience in the pharmaceutical or biopharmaceutical industry to join our growing team. Education &Experience: Bachelor's degree in Engineering (Chemical, Biomedical, Mechanical, or related discipline).

    Numbers & Facts

    LocationHouston, TX

    Description

    Summary :
    We are looking for a Validation Engineer II with experience in the pharmaceutical or biopharmaceutical industry to join our growing team.
    Roles & Responsibilities:
    • Develop and execute IQ, OQ, PQ validation protocols and reports for equipment, utilities, and facilities.
    • Perform CQV activities, including Temperature Mapping for Controlled Temperature Units (CTUs).
    • Collaborate with Manufacturing, QA, Engineering, and R&D teams.
    • Analyze validation data, investigate deviations, and support CAPA implementation.
    • Prepare validation reports and support internal/external audits.
    • Review and support change controls for validated systems.
    Education &Experience :
    • Bachelor's degree in Engineering (Chemical, Biomedical, Mechanical, or related discipline).
    • 2 6 years of validation experience in the pharmaceutical or biopharmaceutical industry.
    • Strong knowledge of cGMP, FDA regulations (21 CFR Parts 210, 211 & 820), and ICH guidelines.
    • Hands-on experience with IQ/OQ/PQ and Temperature Mapping of Controlled Temperature Units is required.

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