Senior CSV Validation Specialist — GxP Compliance Lead

Learn Gmp; New York (NY); On-site; USD 90,000 - 130,000; Full time

Job summary

Learn GMP seeks a CSV Consultant in New York to lead end‑to‑end validation of GxP computer systems (ERP/LIMS/MES/QMS/IT infra). You will craft critical validation deliverables and advise on FDA 21 CFR Part 11, EU Annex 11, and data integrity.

You will interact with clients, manage multiple projects, and contribute to audits, remediation, and knowledge transfer while staying current with regulatory changes.

Qualifications

• 3–7 years of direct CSV experience in regulated life sciences.
• Strong knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+ Data Integrity.
• Experience writing and executing the full suite of validation documentation.
• Experience with LIMS, QMS, ERP and various SDLC/methodologies (Waterfall, V‑Model, Agile).

Responsibilities

• Lead and execute CSV projects across validation lifecycles for GxP systems.
• Develop and review Validation Plans, URS, FS, DS, IQ/OQ/PQ, and reports.
• Provide regulatory expertise on Part 11, data integrity, and predicate rules.
• Apply risk-based validation per GAMP 5 to match system risk and complexity.
• Serve as primary CSV SME for clients, managing stakeholder communication.
• Support audits/inspections, including preparation and response to findings.
• Lead remediation efforts and validate legacy systems.
• Provide training to staff and junior consultants on CSV practices.
• Stay current with evolving global regulations and digital validation trends.

Skills

CSV project leadership

Regulatory compliance

Analytical/problem-solving

Technical writing

Client communication

Time management

Education

Bachelor’s or Master’s degree in IT/Life Sciences

Tools

Documentation tools

Document management systems

Job description

Learn GMP seeks a CSV Consultant in New York to lead end‑to‑end validation of GxP computer systems (ERP/LIMS/MES/QMS/IT infra). You will craft critical validation deliverables and advise on FDA 21 CFR Part 11, EU Annex 11, and data integrity.

You will interact with clients, manage multiple projects, and contribute to audits, remediation, and knowledge transfer while staying current with regulatory changes.