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.
Key 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.