Process Engineer - Solution Prep, Upstream, and Downstream
Core
Design, build, commission, and qualify new equipment and systems for drug substance production (Solution Prep, Upstream, and Downstream) while supporting operations and ensuring GMP compliance.
Role type
Senior IC Process Engineer (Biopharmaceutical Manufacturing)
Builds
Drug substance manufacturing systems and facilities
Domain
Biopharmaceuticals / Upstream and Downstream Processing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, equipment commissioning and qualification, root cause analysis, capital project oversight, system design and modification, maintenance program development, regulatory interaction, risk reduction strategies, data-driven problem solving
Preferred skills
Chemical or Mechanical Engineering background, biopharmaceutical operations experience, statistical process control, predictive maintenance, change control management, technical writing
Technologies
Cell culture reactors, chromatography, viral filtration skids, UFDF skids, CIP systems, autoclaves, clean steam systems, water for injection systems
Responsibilities
Support commissioning and qualification of manufacturing systems in alignment with GMP requirements; ensure systems operate safely and comply with environmental health/safety regulations; assist with new product/technology introductions by performing engineering assessments and implementing equipment modifications; provide system support for biopharmaceutical process equipment and identify engineering-based improvements; develop equipment maintenance programs and coordinate maintenance activities; provide problem solving support to reduce production downtime including technical root cause analysis; provide rotational on-call support to ensure 24x7 day-to-day reliability of systems
Seniority
Mid-Senior, hands-on IC
