Sr. Validation Specialist
Core
Execute validation activities for product launches, facility, equipment, and process development to ensure regulatory compliance and client expectations.
Role type
Senior IC validation specialist (biopharma)
Builds
Qualified instruments, equipment, facilities, utilities, automated systems, and manufacturing processes for biopharma clients
Domain
Biopharmaceutical manufacturing and regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Equipment Qualification (IQ/OQ/PQ), Process Validation (PV), New Product Introduction (NPI), Deviation management, CAPA processes, Root Cause Analysis, Regulatory inspection support, Change control support, Periodic reviews and revalidations
Preferred skills
Secondary/blister packaging validation, High-speed/automated line validation, Risk-based project validation strategy, Cleaning Validation (CV), Computer Systems Validation (CSV), Temperature mapping, FAT/SAT execution
Technologies
VMPs, specifications, protocols, reports, automated systems, cold stores, utilities
Responsibilities
Support validation efforts for strategic projects; Prepare, review, and approve qualification/validation documentation; Drive solutions for customer-related validation problems; Execute validation activities with minimal supervision; Coordinate packaging validation activities; Perform periodic reviews and revalidations; Support regulatory inspections and customer audits
Seniority
Senior, hands-on IC
