Senior Process Engineer - CIP/SIP/Autoclaves
Core
Design, build, commission, and qualify CIP, SIP, and Autoclave systems for drug substance production in a biopharmaceutical manufacturing plant.
Role type
Senior Process Engineer (Facilities & Engineering)
Builds
Drug substance manufacturing equipment and systems (CIP skids, SIP circuits, autoclaves, process tanks, valves, instrumentation)
Domain
Biopharmaceutical manufacturing / Chemical Engineering
Required skills
CIP/SIP/Autoclave system design, GMP compliance, commissioning and validation, lifecycle support, root cause analysis, maintenance program development, equipment modification, technical writing
Preferred skills
Chemical or Mechanical Engineering degree, 6+ years biopharmaceutical operations experience, Tech Transfer, Process Design, cGMP/OSHA/EPA regulations, 24/7 shift support
Technologies
CIP skid systems, SIP circuits, autoclaves, transfer panels, process tanks, valves, instrumentation, automation platforms, UFDF skids, viral filtration skids
Responsibilities
Support design and build of manufacturing equipment systems, execute commissioning and validation, lead engineering-based improvements, develop master maintenance programs, provide rotational on-call support, lead new product/technology introductions
Seniority
Senior, hands-on IC
