Job Description

Role: Computer System Validation (CSV) / GxP Validation Consultant

Location: 100% Remote


Duration: Long Term Contract

Environment: Highly regulated GxP environment

What the client is looking for
• Strong CSV professional with hands-on experience executing the full validation lifecycle including requirements gathering, risk assessments, test script creation/execution, IQ/OQ/PQ, traceability, deviations, and maintaining validated systems.
• Deep expertise with 21 CFR Part 11, EU Annex 11, Data Integrity, GAMP 5, audit trails, electronic signatures, access controls, and validation documentation, with the ability to support audits and partner closely with QA, Compliance, Business, and IT teams.

Key Skills


Computer System Validation (CSV), GxP, GAMP 5, 21 CFR Part 11, EU Annex 11, Data Integrity, Validation Plans, IQ/OQ/PQ, Risk Assessments, Traceability Matrix, Test Script Development, Change Control, CAPA, Audit Readiness, SDLC, Quality Systems, Regulatory Compliance

Preferred Background

• Pharmaceutical, biotechnology, life sciences, or medical device industry experience
• Validation of regulated applications such as LIMS, MES, QMS, ERP, Laboratory Systems, Manufacturing Systems, or Clinical Systems
• Experience supporting FDA, EMA, and regulatory inspections
• Strong documentation and stakeholder communication skills
• Ability to operate independently and drive validation efforts across cross-functional teams

Job Tags

Long term contract, Remote work

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