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Validation Engineer Jobs in Florida

CSV Validation Engineer

Katalyst Healthcares & Life Sciences

  • Jacksonville, FL
  • 30+ days ago

    Highlights

    Education & Experience: 8 years Experience in Computer System Validation / CSV within pharmaceutical, biotech, medical device, or other regulated environments. Collaborate with QA, IT, Engineering, Manufacturing, and business stakeholders to ensure systems meet intended use and compliance requirements.

    Numbers & Facts

    LocationJacksonville, FL

    Description

    Summary:
    We are currently looking for an experienced CSV (Computer System Validation) Engineer to join our team in Plymouth, MN.
    Roles & Responsibilities:
    • Develop and execute Computer System Validation (CSV) strategies, plans, protocols, and reports.
    • Create and maintain validation documentation including URS, FS, DS, IQ, OQ, PQ, and validation summary reports.
    • Perform risk assessments, impact assessments, traceability, and change control activities.
    • Support validation of GxP-regulated computerized systems in accordance with applicable regulations and company procedures.
    • Collaborate with QA, IT, Engineering, Manufacturing, and business stakeholders to ensure systems meet intended use and compliance requirements.
    • Execute and document test scripts, deviations, investigations, and CAPA activities.
    • Ensure compliance with FDA, GxP, GMP, 21 CFR Part 11, and data integrity requirements.
    • Support system implementation, upgrades, remediation, periodic reviews, and decommissioning activities.
    • Participate in audits and provide validation documentation and evidence as required.
    Education & Experience:
    • 8 years Experience in Computer System Validation / CSV within pharmaceutical, biotech, medical device, or other regulated environments.
    • Strong knowledge of GxP, GMP, FDA regulations, 21 CFR Part 11, and data integrity.
    • Experience with validation methodologies, risk-based validation, and electronic documentation.
    • Excellent documentation, communication, and stakeholder-management skills.

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