Senior CSV Validation Lead — Pharma GxP & 21 CFR Expert

Weltraw Consulting Group; New York (NY); On-site; USD 120,000 - 180,000; Full time

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

CSV/CQV

GxP compliance

Technical writing

Client communication

Education

Bachelor's degree in Engineering/CS/Life Sciences

Tools

Veeva Vault

TrackWise

LIMS

Job description

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.