Principal Process Engineer - Upstream/Downstream
Core
Design, build, commission, and qualify new equipment and systems for Upstream and Downstream drug substance production at a biopharmaceutical manufacturing plant.
Role type
Principal Process Engineer (Upstream/Downstream)
Builds
Drug substance manufacturing systems and facilities
Domain
Biopharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, equipment design, commissioning and validation, root cause analysis, project leadership, maintenance program development, risk assessment, technical mentorship
Preferred skills
Chemical or Mechanical Engineering background, 8+ years in biopharmaceutical process/plant engineering, experience with cell culture reactors, chromatography, viral filtration skids, UFDF skids, CIP systems, and water for injection systems, Tech Transfer and Process Design experience
Technologies
GMP, OSHA, EPA regulations, building and process automation systems
Responsibilities
Support design and build of manufacturing equipment systems including equipment design, sizing, and piping and instrumentation diagrams; Execute commissioning and validation of systems to ensure operational capability aligns with manufacturing requirements and GMP regulations; Provide system ownership for Upstream and/or Downstream process equipment ensuring end-to-end support for operations; Lead identifying and implementing engineering-based improvements or upgrades to process equipment systems; Provide technical mastery and problem-solving leadership to proactively reduce production downtime; Provide mentorship and coaching to junior engineering peers; Provide rotational on-call support to ensure 24x7 day-to-day reliability of systems
Seniority
Principal, hands-on IC with leadership responsibilities
