Computer Systems Validation Engineer
Core
Lead Computer System Validation strategy and operations for GxP technology portfolios in a biotech company, ensuring compliance and data integrity while scaling validation capabilities.
Role type
Lead Computer System Validation Engineer (Strategy & Team Lead)
Builds
Scalable CSV operating model, standards, and team capabilities for GxP systems
Domain
Biotechnology / Pharmaceutical / Regulated IT
Required skills
Computer System Validation (CSV), Computer Software Assurance (CSA), GxP requirements, GAMP 5, risk-based validation, 21 CFR Part 11, EU Annex 11, ALCOA+ data integrity, change control, deviations, CAPA, document control, IQ/OQ/PQ/UAT, regulatory inspection support, team leadership, validation strategy definition
Preferred skills
Scripting, SQL, test automation, validation automation, electronic document management, quality management, issue-tracking tools
Responsibilities
Define validation strategy, operating model, and standards; author and maintain validation lifecycle deliverables (plans, protocols, traceability matrices); build and mentor the CSV team; execute risk-based qualification and verification activities; assess system changes and support regression testing; manage validation maintenance and decommissioning; investigate deviations and contribute to CAPA; prepare evidence for audits and inspections; collaborate with cross-functional teams to translate compliance needs into scalable strategies; improve validation procedures and templates; utilize automation and AI-assisted tools for efficiency.
Seniority
Lead, hands-on IC with team leadership