Senior CSV Engineer

About the role

We are looking for a Senior CSV Engineer to lead validation projects for our top-tier pharma clients. You will be responsible for defining validation strategies, executing protocols, and ensuring compliance with 21 CFR Part 11.

Responsibilities

• Develop Validation Master Plans (VMP) and Traceability Matrices.
• Execute IQ/OQ/PQ protocols for GxP systems.
• Lead risk assessments (FMEA) and define mitigation strategies.
• Mentor junior engineers and review their deliverables.
• Interface with client Quality Assurance teams to defend validation strategies.

Requirements

• BS in Engineering, Computer Science, or Life Sciences.
• 7+ years of experience in CSV/CQV in the pharmaceutical industry.
• Deep understanding of GAMP5, 21 CFR Part 11, and Annex 11.
• Experience with Veeva Vault, TrackWise, or LIMS systems is a plus.
• Strong technical writing and communication skills.