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🥝 CSV Engineer

Katalyst Healthcares & Life Sciences | New Wilmington, Pennsylvania, United States | Posted May 04, 2026

Job Description


Job Summary:

The CSV Engineer / Validation Engineer will be responsible for ensuring computerized systems in a regulated pharmaceutical environment comply with GxP, 21 CFR Part 11, GAMP 5, EU Annex 11, ISO 9001, and SOX requirements. The role involves supporting validation activities using a risk-based approach aligned with CSA principles, ensuring systems are audit-ready, and maintaining compliance throughout the system lifecycle. The position also requires hands-on involvement in documentation, validation execution, and quality governance for enterprise systems such as Veeva Vault, SAP GxP modules, and LIMS platforms.



Roles & Responsibilities:


  • Ensure compliance of computerized systems with regulatory standards including 21 CFR Part 11, GxP, GAMP 5, EU Annex 11, ISO 9001, SOX, and ITIL frameworks.

  • Perform audit readiness activities including periodic system reviews, access control evaluati...

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