PROJECT ENGINEER
Core
Leads the project from initial design studies to final validation of equipment, process systems, and utilities for aseptic manufacturing.
Role type
Senior IC project engineer (pharmaceutical manufacturing)
Builds
Manufacturing equipment, process systems, and validation protocols for aseptic production
Domain
Pharmaceutical manufacturing / Aseptic processing
Required skills
Engineering studies, design space development, validation protocols (URS, HDS, SDS, FRS, FAT, SAT, DQ, IQ, OQ, PQ), risk analysis (FMEA, Fishbone), project budgeting, vendor management, equipment installation supervision, process optimization
Preferred skills
Experience with sterilizers, lyophilizers, automated decontamination, CIP/SIP, formulation, filling, depyrogenation, inspection, packaging
Technologies
CIP/SIP, Lyophilizers, Sterilizers, Automated Decontamination, Parts Washer, Formulation, Filling, Depyrogenation, Inspection, Packaging
Responsibilities
Conduct engineering studies to develop design space for manufacturing construction; Develop and manage site projects using research, design, and concept sketches; Execute validation studies and prepare protocols for regulatory agencies; Develop and maintain process instructions for manufacturing equipment; Act as primary resource for cycle development and optimization on aseptic manufacturing equipment; Prepare funding requests and project justifications; Manage and supervise equipment installation, vendor selection, and facility modifications; Assist Manufacturing and Maintenance with problem-solving and process improvement