Senior Fill Finish Manufacturing Engineer
Core
Technical subject matter expert for medical device and combination product assembly design, selection, and process development in fill/finish operations.
Role type
Senior IC manufacturing engineer (fill/finish)
Builds
Medical device and combination product assembly, labeling, and packaging processes
Domain
Biopharmaceutical manufacturing (injectable products)
Required skills
cGMP manufacturing knowledge, assembly/labeling/packaging of liquid and lyophilized injectables, technology transfer, equipment/process validation, aseptic operations, capital investment planning
Preferred skills
Highly automated equipment operation, serialization systems, aseptic parenteral fill/finish validation
Technologies
serialization systems, automated fill/finish equipment
Responsibilities
Lead material and component selection and approval; support equipment design, installation, and qualification; drive innovation in manufacturing equipment and techniques; represent manufacturing during regulatory and client audits; serve as primary interface between operations and Engineering/Validation/Quality Assurance
Seniority
Senior, hands-on IC
