Senior Validation Specialist
Core
Lead, execute, and oversee filter qualification and validation programs for sterile manufacturing processes and equipment to ensure regulatory compliance and operational excellence.
Role type
Senior Validation Specialist (cGMP)
Builds
Validated production processes, equipment, and sterile manufacturing systems for vaccines, biologics, and small molecule drug products.
Domain
Biopharmaceutical manufacturing / Sterile processing
Required skills
cGMP validation, filter qualification, sterile/aseptic processing, root-cause analysis, change control management, audit readiness, project leadership, Lean/Six Sigma problem-solving, technical documentation, risk assessment
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead comprehensive filter qualification and validation studies; drive development and lifecycle management of new production processes; support technology transfers and commercial scale-ups; spearhead technical investigations and troubleshooting for validation deviations; generate and approve critical validation documentation; champion change controls and corrective actions; support regulatory agency inspections; foster a safe, inclusive culture.
Seniority
Senior, hands-on IC