📍 Local Job Near You
CSV Lead
Katalyst Healthcares & Life Sciences
📍
South Plainfield, New Jersey, United States
Location
South Plainfield, New Jersey
Posted
May 16, 2026
Commute
Local Area
Local Opportunity Near You!
This job is in your area. Enjoy a short commute and work close to home.
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.