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Senior CSV Analyst

Karwell Technologies

  • San Francisco, CA
  • 1 day ago

    Highlights

    We are seeking an experienced Senior Computer System Validation (CSV) Analyst to support validation and compliance activities for GxP computerized systems in a regulated pharmaceutical/biotechnology environment. Develop and maintain Validation Plans, User Requirements Specifications (URS), Functional Specifications (FS), Risk Assessments, test protocols, and validation reports.

    Numbers & Facts

    LocationSan Francisco, CA

    Description

    Job Description:
    We are seeking an experienced Senior Computer System Validation (CSV) Analyst to support validation and compliance activities for GxP computerized systems in a regulated pharmaceutical/biotechnology environment. The ideal candidate will have strong knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, risk-based validation, and Computer Software Assurance (CSA) principles.
    Responsibilities:
    • Lead and execute Computer System Validation (CSV) activities throughout the system lifecycle.
    • Develop and maintain Validation Plans, User Requirements Specifications (URS), Functional Specifications (FS), Risk Assessments, test protocols, and validation reports.
    • Execute and document IQ/OQ/PQ, UAT, regression, and risk-based testing as applicable.
    • Ensure computerized systems remain in a validated state throughout their lifecycle.
    • Perform GxP impact assessments, validation risk assessments, and system categorization.
    • Apply GAMP 5 and CSA principles to validation strategies and testing approaches.
    • Support 21 CFR Part 11 and EU Annex 11 compliance assessments.
    • Review system requirements, specifications, test scripts, and traceability matrices.
    • Support Change Control, Deviation, CAPA, and Periodic Review activities.
    • Review and assess audit trails, user access, electronic records, and electronic signatures.
    • Support internal audits and FDA/regulatory inspection readiness.
    • Collaborate with IT, Quality Assurance, Business Process Owners, System Owners, and vendors.
    • Identify validation gaps and develop appropriate remediation strategies.
    • Ensure validation documentation is accurate, complete, traceable, and inspection-ready.
    • Support system upgrades, implementations, migrations, and integrations.
    • Provide technical guidance and mentoring to junior CSV team members.
    Requirements:
    • Bachelor's degree in Computer Science, Information Technology, Engineering, Life Sciences, Pharmacy, or a related field.
    • 5 8+ years of experience in Computer System Validation, Quality Systems, or GxP IT environments.
    • Strong experience validating GxP computerized systems in pharmaceutical, biotechnology, medical device, or other regulated industries.
    • Hands-on experience with GAMP 5, 21 CFR Part 11, EU Annex 11, and CSA.
    • Experience with enterprise GxP applications such as Veeva, SAP, LIMS, MES, QMS, ERP, or clinical systems is preferred.
    • Strong technical writing, analytical, problem-solving, and communication skills.
    • Ability to manage multiple validation projects and priorities in a regulated environment.

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