Senior Computer System Validation Analyst
Core
Provide hands-on validation and compliance support for computerized manufacturing systems in a regulated pharmaceutical environment.
Role type
Senior Computer System Validation Analyst
Builds
Validation lifecycle deliverables (IQ/OQ/PQ, change control, CAPA) for manufacturing automation platforms
Domain
Pharmaceutical manufacturing / GxP-regulated environments
Required skills
Computer System Validation (CSV), GMP compliance, validation lifecycle management, risk management, change control, CAPA, data integrity, GxP regulations, SDLC, qualification (IQ/OQ/PQ), manufacturing automation platforms (DeltaV, Rockwell, Siemens PLC)
Preferred skills
PLC Security
Responsibilities
Review and approve validation documentation and compliance deliverables; advise project teams on SDLC, CSA, qualification, risk-based validation, and change control processes; support CSV compliance for capital and strategic projects.
Seniority
Senior, hands-on IC