Computer System Validation Senior Analyst
Core
Lead and manage the end-to-end Computer System Validation (CSV) lifecycle for FDA-regulated computer systems used in development, manufacturing, and distribution.
Role type
Senior IC Computer System Validation Lead
Builds
Validated computer systems for FDA-regulated products
Domain
Life Sciences / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
FDA regulations (21 CFR Part 11, 820, GAMP), CSV lifecycle management, risk assessment, IQ/OQ/PQ/UAT execution, SDLC methodologies, project management, LIMS/EDC/MES familiarity
Preferred skills
Advanced degree, automated validation solutions, electronic document management systems (EDMS), validation software
Technologies
LIMS, EDC, MES, EDMS
Responsibilities
Lead CSV lifecycle planning, execution, documentation, and approvals; Develop and maintain validation plans, protocols, risk assessments, and traceability matrices; Conduct risk assessments and impact analyses; Design and execute validation testing activities (IQ, OQ, PQ, UAT); Provide oversight, guidance, and training on CSV best practices; Support audits and resolve compliance issues
Seniority
Senior, hands-on IC
