Associate Director Principal Engineer
Core
Provides technical support for process manufacturing, leads technology transfers, and optimizes productivity and yield for oral solid dose pharmaceutical products.
Role type
Senior IC process engineering leader (pharmaceutical manufacturing)
Builds
Robust manufacturing processes, validated equipment, and scalable production systems for tablets and capsules
Domain
Pharmaceutical manufacturing (Oral Solid Dose)
Required skills
cGMP compliance, process troubleshooting, root-cause analysis, technology transfer, process validation, scale-up, statistical process control, equipment modification, project management
Preferred skills
Lean Manufacturing, Six Sigma, IQ/OQ/PQ, Statistical Process Control, Process Capability Analysis
Technologies
Process Analytical Technologies (PAT), cGMP systems, manufacturing automation
Responsibilities
Investigate and correct process-related problems and deviations; lead technology transfers from R&D and other sites; execute process validation studies; optimize productivity and yield; conduct scale-up activities; author and approve area procedures and master batch records; mentor new engineers; implement equipment modifications; support regulatory inspections
Seniority
Senior, hands-on IC with leadership responsibilities