CSV Lead
Location
South Plainfield, New Jersey
Job Type
Full-time
Category
other-general
Posted
May 16, 2026
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.