Senior Process Engineer - Solution Prep, Upstream, and Downstream
Core
Design, build, commission, and qualify new equipment and systems for drug substance production, providing end-to-end support for Solution Prep, Upstream, and Downstream process operations.
Role type
Senior Process Engineer (Biopharmaceutical Manufacturing)
Builds
Drug substance manufacturing systems and equipment for Solution Prep, Upstream, and Downstream processes
Domain
Biopharmaceutical manufacturing / Chemical Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, equipment design and sizing, piping and instrumentation diagrams, commissioning and validation, root cause analysis, corrective and preventative actions, maintenance program development, technical writing
Preferred skills
Chemical or Mechanical Engineering degree, 6+ years in biopharmaceutical operations, experience with cell culture reactors, chromatography, viral filtration skids, UFDF skids, Tech Transfer, Process Design
Technologies
cGMP, OSHA, EPA, change control, non-conformances, clean in place (CIP) systems, washers, clean steam, water for injection
Responsibilities
Support design and build of manufacturing equipment systems, execute commissioning and validation of systems, lead identifying and implementing engineering-based improvements, develop master maintenance programs, provide rotational on-call support for 24x7 reliability, lead new product/technology introductions
Seniority
Senior, hands-on IC
