Sterile New Product Program Engineer
Core
Execute engineering activities to prepare facilities, utilities, and equipment for a new aseptic cartridge-filling process, ensuring systems are designed, installed, qualified, and validated in compliance with GMP and regulatory requirements.
Role type
Senior IC pharmaceutical manufacturing engineer (sterile/aseptic)
Builds
Aseptic cartridge-filling product line
Domain
Healthcare / Pharmaceutical manufacturing
Required skills
Equipment qualification and validation, GMP and regulatory standards knowledge, Cleanroom operations and contamination control, Utilities systems management, Automation systems familiarity, Project management, Process characterization
Preferred skills
Lean Six Sigma, PMP certification, Sterile/aseptic environment experience
Technologies
RABS/ORABS systems, PLC/SCADA, WFI, Clean steam, HVAC, Media fills
Responsibilities
Support facility modifications and readiness activities for aseptic processing areas, Execute commissioning and qualification activities (IQ/OQ/PQ), Develop and review URS, FAT/SAT, and validation protocols, Support PPQ batch execution and Exhibit batches in manufacturing, Train operators on new equipment and processes
Seniority
Mid-Senior, hands-on IC