Process Validation Expert
Core
Ensure manufacturing processes remain robust, compliant, and inspection-ready by leading process validation activities across the product lifecycle.
Role type
Process Validation Expert (Manufacturing)
Builds
Reliable product supply for life-changing medicines
Domain
Pharmaceutical manufacturing / Biotechnology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (Manufacturing processes)
Required skills
Process validation lifecycle management, GMP compliance, root cause analysis, change control management, statistical analysis, manufacturing execution systems, enterprise resource planning systems
Preferred skills
Upstream and downstream biotechnology processes, risk assessment, protocol and report writing, JMP, Minitab
Technologies
Manufacturing execution systems, enterprise resource planning systems, JMP, Minitab
Responsibilities
Serve as Subject Matter Expert for assigned products and processes, support investigations of process deviations, oversee process changes through formal change control, lead process validation lifecycle activities, support internal and external inspections, evaluate process performance trends
Seniority
Mid-level, hands-on IC