Principal Engineer, Fill and Finish, Technical Operations
Core
Lead engineering strategy and execution for aseptic fill/finish operations to improve drug product manufacturing capability in a CDMO setting.
Role type
Principal Engineer, Technical Operations (Fill/Finish)
Builds
Drug product manufacturing capabilities for genomic medicine and biotechnology clients
Domain
Life sciences / Biotechnology / CDMO / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Aseptic processing, cGMP compliance, contamination control, risk assessment, validation lifecycle management, equipment lifecycle management, audit support, CAPA leadership, process robustness development
Preferred skills
Experience with automated/semi-automated fillers, isolators, cappers, inspection systems, secondary packaging lines
Technologies
URS, FAT/SAT, commissioning, IQ/OQ/PQ, APS, CCIT, EMPQ
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; Maintain sterility assurance programs
Seniority
Principal, hands-on IC with mentorship
