Role: CSV Lead (Computer System Validation Lead) Location: Remote Contract
Job Summary The CSV Lead will be responsible for leading and managing Computer System Validation (CSV) activities to ensure compliance with regulatory requirements such as FDA 21 CFR Part 11, GxP, and industry best practices. The role involves overseeing validation strategies, documentation, risk assessments, and coordination with cross-functional teams.
Key Responsibilities
Lead end-to-end Computer System Validation activities for GxP-regulated systems
Develop and execute validation plans, protocols, and reports (VP, IQ, OQ, PQ)
Ensure compliance with FDA, EMA, 21 CFR Part 11, GAMP 5, and data integrity guidelines
Perform risk assessments and define validation strategies based on system impact
Review and approve CSV deliverables and validation documentation
Coordinate with QA, IT, Business, and Vendors during validation lifecycle
Support audits, inspections, and regulatory submissions
Manage change control, deviation, CAPA, and periodic reviews
Mentor and guide CSV team members and provide technical leadership
Ensure validation activities align with SDLC and Agile methodologies