Computer System Validation Lead
Core
Lead the validation and implementation of infrastructure systems for applications within the pharmaceutical, biotechnology, or medical device industry.
Role type
Senior Computer System Validation (CSV) Lead
Builds
Validated infrastructure systems and compliance documentation for regulated environments
Domain
Life Sciences (Pharmaceutical, Biotechnology, Medical Device)
Required skills
Computer System Validation (CSV), System Development Lifecycle (SDLC), GxP standards, FDA guidance, GAMP, risk-based validation, validation documentation, test protocols, traceability matrices, QA methodologies
Preferred skills
Leading teams, remote collaboration, issue escalation
Technologies
Infrastructure systems, validation tools
Responsibilities
Validate and implement infrastructure systems; Write and execute validation documentation; Review system and UAT scripts, traceability matrices, and design specifications; Design, review, and approve test plans and procedures; Provide validation guidance and escalate issues; Support remote teams and multiple projects simultaneously
