Principal Engineer, Fill and Finish, Technical Operations
Core
Build and deliver Fill/Finish engineering strategy to improve and grow Drug Product manufacturing capability for aseptic fill/finish operations.
Role type
Principal Engineer, Technical Operations (Fill/Finish)
Builds
Drug Product manufacturing capability and aseptic fill/finish operations
Domain
Life sciences / Biotechnology / CDMO / Pharmaceutical manufacturing
Required skills
Aseptic processing, Contamination control, Process validation, Risk assessment, Equipment lifecycle management, Regulatory compliance (cGMP, USP, EU), Audit support, CAPA management, Equipment expertise (fillers, isolators, cappers, inspection systems, secondary packaging)
Preferred skills
CDMO experience, Drug product manufacturing facility experience
Technologies
Automated fillers, Semi-automated fillers, Isolators, Cappers, Inspection systems, Secondary packaging lines
Responsibilities
Serve as subject matter expert for aseptic fill/finish operations; Develop engineering strategies for process robustness and validation; Lead deviations, investigations, and risk assessments; Support equipment lifecycle activities (URS, FAT/SAT, commissioning, IQ/OQ/PQ); Support PPQ strategies and validation lifecycle management.
Seniority
Principal, hands-on IC with mentorship