Senior Validation Engineer
Core
Planning, scheduling, executing, and leading validation projects for manufacturing processes, equipment, utilities, and sterile product cycles to ensure patient safety and regulatory compliance.
Role type
Senior Validation Engineer (Pharmaceutical Manufacturing)
Builds
Validated manufacturing processes, equipment, and sterile product cycles for patient care products
Domain
Pharmaceutical manufacturing and sterile processing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (validation of physical systems and processes)
Required skills
Good Manufacturing Practices (GMP), validation lifecycle documentation (FRS, URS, FAT, SAT, DQ, IQ, OQ, PQ), risk assessment, gap analysis, deviation investigation, process capability analysis, aseptic gowning techniques, change control review
Preferred skills
sterile product validation, medical device validation, regulatory audit support, AI tool utilization for problem solving
Technologies
Global Document Management System, System Application & Products, Quality Tracking System
Responsibilities
Develop validation master plans and protocols, support corrective actions for deviations, conduct process capability analysis, prepare Annual Product Quality Reports, lead projects to reduce process risk, perform aseptic gowning in cleanrooms
Seniority
Senior, hands-on IC