Computer System Validation (CSV) Lead (AI,GenAI Platforms), Hybrid - 69387

We are seeking an experienced Validation Lead with strong Computer System Validation (CSV) expertise to support GenAI and Agentic QMS solutions in a GxP-regulated pharmaceutical environment.

This is a hybrid position based in Raritan, NJ for a candidate with proven experience in Computer System Validation (CSV), FDA regulations, GxP compliance, GAMP 5, SDLC, Validation Planning, Requirements Management, Risk-Based Validation, User Requirements Specifications (URS), Validation Plans, Test Protocols, User Acceptance Testing (UAT), Traceability Matrix (RTM), Test Summary Reports, Validation Reports, QA methodologies, Design Specifications, Change Management, and GenAI/Agentic QMS validation.

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No subcontracting is permitted on this position. Candidates must be willing to work directly on our payroll.

For immediate consideration, please contact:

Arun
PRIMUS Global Services
Phone:
Email: