Validation Specialist 3
Core
Own high-risk validation projects for biopharma clients, ensuring compliance with cGMP/GAMP/21CFR standards and delivering validated processes for product/system launches.
Role type
Senior IC Validation Specialist (High-Risk Projects)
Builds
Validated processes, protocols, and reports for new customer/product/system launches
Domain
Biopharmaceuticals / Quality Assurance / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation protocol design, audit preparation, deviation investigation, change control management, regulatory standards interpretation (cGMP/GAMP/21CFR), project coordination
Preferred skills
Process/Cleaning validation (packaging/biopharma), HVAC/Utility validation, Computer system validation (cGXP/Annex 11)
Technologies
Computer systems impacting cGMP/cGXP, HVAC control systems, packaging operations
Responsibilities
Generate and execute validation protocols, prepare validation statements and master plans, investigate deviations and document corrective actions, coordinate internal and customer approvals, prepare change control and validation history reports
Seniority
Mid-level, hands-on IC
