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🥝 CSV Lead
Katalyst Healthcares & Life Sciences | South Plainfield, New Jersey, United States | Posted May 16, 2026
Job Description
Roles and Responsibilities:
- Lead end-to-end Computer System Validation for GxP systems.
- Develop and review URS, risk assessments, IQ/OQ/PQ protocols, and validation reports.
- Ensure compliance with FDA 21 CFR Part 11, GAMP 5, and GxP.
- Manage validation risk and maintain systems in a validated state.
- Collaborate with IT, QA, Labs, and vendors.