Spécialiste senior en validation (CSV) / Senior Validation Specialist (CSV)
Core
Ensures compliance and manages the lifecycle of regulated laboratory equipment and computerized systems, including complex Excel spreadsheets, within a clinical research environment.
Role type
Senior Validation Specialist (CSV)
Builds
Validated laboratory equipment, computerized systems, and complex Excel spreadsheets for clinical research clients
Domain
Life sciences / Clinical research / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation lifecycle management, risk assessment, IQ/OQ/PQ protocol development, regulatory compliance (21 CFR Part 11, GAMP5, GLP), project coordination, system administration, environmental monitoring, technical troubleshooting
Preferred skills
Mentorship of junior specialists, stakeholder collaboration, complex Excel development
Technologies
Excel, GAMP5, 21 CFR Part 11, NIST, GCLP, GLP
Responsibilities
Lead multiple validation projects to timely delivery, write and approve validation deliverables (plans, reports, protocols), oversee full lifecycle management of equipment and software, administer access to regulated systems, provide expert technical support and troubleshooting, administer environmental monitoring systems, mentor junior validation specialists
Seniority
Senior, hands-on IC
