Principal Quality Engineer - Contamination Control Strategy
Core
Lead and manage quality projects, drive continuous improvement of the Global Contamination Control Strategy, and bridge conceptual design with practical manufacturing in pharmaceutical operations.
Role type
Principal Quality Engineer (Contamination Control Strategy)
Builds
Pharmaceutical manufacturing processes, contamination control systems, and quality management improvements
Domain
Pharmaceutical manufacturing / Contamination Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (manufacturing process control)
Required skills
Risk management (FMEA, fault tree analysis), Root cause analysis, CAPA implementation, Environmental monitoring, Cleanroom operations, Cost of Quality analysis, Change management, Project leadership, Statistical data analysis, Audit preparation
Preferred skills
Microbiology, Sterility assurance, Water/steam/compressed air systems, Lean principles (Kaizen, value stream mapping), pFMEA development, Investigation leadership
Technologies
FMEA, Fault tree analysis, Lean tools, Statistical techniques
