Senior Process Engineer
Core
Design, build, commission, and qualify new equipment and systems for drug substance production, focusing on Downstream Process engineering.
Role type
Senior Process Engineer (Biopharmaceutical Manufacturing)
Builds
Drug substance production systems and equipment
Domain
Biopharmaceutical manufacturing / Downstream processing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, equipment design and specification, root cause analysis, capital project oversight, validation protocols, risk assessment, maintenance program development
Preferred skills
Chemical or Mechanical Engineering background, 6+ years in biopharmaceutical operations, experience with cell culture reactors, chromatography, tangential flow filtration, cGMP environments, statistical process control, Six Sigma
Technologies
cGMP systems, CIP systems, autoclaves, clean steam, water for injection systems
Responsibilities
Provide system ownership for biopharmaceutical process equipment; lead implementation of engineering improvements; develop equipment maintenance programs; ensure safety and regulatory compliance; support new product/technology introductions; provide 24/7 rotational on-call support; lead technical root cause analysis to reduce downtime.
Seniority
Senior, hands-on IC
