Senior CSV Analyst
Core
Lead computer system validation (CSV) compliance activities for capital and strategic projects in regulated pharmaceutical or biotechnology environments.
Role type
Senior CSV Analyst (Regulatory Compliance)
Builds
Validation lifecycle deliverables, compliance trackers, metrics, and reports for manufacturing automation and laboratory systems.
Domain
Life Sciences / Pharmaceutical / Biotechnology / Regulatory Compliance
Required skills
Computer System Validation (CSV), Computer Software Assurance (CSA), GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11, risk-based validation, SDLC, change management, deviation processes, PLC, DeltaV, PI Historian, laboratory automation systems, capital project support
Preferred skills
Stakeholder management, independent work across multiple sites
Technologies
DeltaV, PI Historian, PLC, GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11
Responsibilities
Lead CSV compliance activities for capital and strategic projects; Develop, review, and approve validation lifecycle deliverables; Advise project teams on SDLC, CSA, qualification, and validation approaches; Participate in project meetings and CSV compliance reviews; Support project change controls and CSV compliance-related risk assessments; Maintain project CSV compliance trackers, metrics, and reports; Approve SDLC documents as part of the technical unit.
