Senior Principal Process Engineer, Visual Inspection (MSAT)
Core
Lead end-to-end Visual Inspection (VI) program management for a greenfield biopharma facility, developing compliant processes from kit building to high-speed automated inspection for drug products.
Role type
Senior Principal Process Engineer (Visual Inspection)
Builds
End-to-end VI processes and automated inspection systems for drug products
Domain
Biopharmaceutical manufacturing / Visual Inspection
Required skills
cGMP operations, visual inspection systems (automated/semi-automated/manual), process validation, root cause analysis, data analysis, statistical tools, project management
Preferred skills
qualification and validation protocols, Lean Six Sigma
Technologies
Knapp, automated eject inspection, MSAT Lab
Responsibilities
Provide technical expertise for visual inspection operations (syringe and cartridge), act as primary point of contact for the Global MSAT network, participate in process validation activities, design reject material classifications and defect libraries, defend the VI program in regulatory inspections, perform data gathering and root cause analysis, support deviation investigations, recommend corrective and preventive actions, participate in technology transfer activities
Seniority
Senior Principal, hands-on IC with strategic program leadership
