Senior CSV Engineer
Weltraw Consulting Group
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Job summary
Weltraw Consulting Group in New York seeks a Senior CSV Engineer to lead validation projects for top-tier pharma clients. You will define validation strategies, develop VMPs and IQ/OQ/PQ protocols to ensure compliance with GxP and 21 CFR Part 11.
You will mentor junior engineers, conduct risk assessments (FMEA), and interface with client QA teams to defend validation approaches. A strong background in GAMP5 and experience with Veeva Vault, TrackWise, or LIMS is highly valued.
Qualifications
- BS in Engineering, Computer Science, or Life Sciences.
- 7+ years of CSV/CQV experience in the pharmaceutical industry.
- Strong knowledge of GAMP5, 21 CFR Part 11, and Annex 11.
- Experience with Veeva Vault, TrackWise, or LIMS is a plus.
- Excellent technical writing and communication skills.
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.
Skills
Education
Tools
Job description
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.
- 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.
- 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.
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