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CVS Lead

Katalyst HealthCares & Life Sciences
📍 South Plainfield, New Jersey, United States 💼 Full-time 🕒 Posted July 02, 2026
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Job Description


Job Summary
The CVS Lead is responsible for leading Computer System Validation activities for GxP-regulated systems to ensure compliance with global regulatory standards. The role involves managing validation lifecycle activities, coordinating with cross-functional teams, and ensuring audit readiness.

Key Responsibilities:
  • Lead Computer System Validation (CSV) activities across multiple GxP systems

  • Own and manage CSV lifecycle (Plan, Requirements, Risk Assessment, IQ, OQ, PQ)

  • Ensure compliance with CFR Part , EU Annex , GAMP

  • Review and approve validation deliverables: Validation Plans (VP)
    User Requirement Specifications (URS)
    Functional & Design Specifications (FS/DS)
    Risk Assessments
    Test Scripts & Traceability Matrix

  • Provide CSV governance for: ERP (SAP)
    LIMS, MES, QMS
    Laboratory instruments & interfaces

  • Lead and support regulatory audits & inspections (FDA, EM...

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    Job Details

    • Location South Plainfield, New Jersey
    • Job Type Full-time
    • Category Operations Specialties Managers
    • Posted Date July 02, 2026
    • Application Deadline August 11, 2026