Process Engineer III
Core
Support the startup and long-term operation of a new large molecule manufacturing facility, focusing on upstream processing and large-scale stainless steel biologics environments.
Role type
Senior Process Engineer (Biologics Manufacturing)
Builds
Large-scale stainless steel biologics manufacturing facilities and validated manufacturing systems
Domain
Biopharmaceuticals / Upstream Processing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP manufacturing operations, upstream processing equipment, stainless steel facility experience, FDA regulations, change control, CAPA implementation, equipment reliability strategies, URS/FS/DDS documentation, bioreactor/filtration/chromatography systems, technical writing
Preferred skills
Utility systems (WFI, Clean Steam), facility startup, equipment qualification, commissioning, technology transfer
Responsibilities
Support design, installation, qualification, and startup of new manufacturing facility; Provide engineering support for upstream/downstream process equipment; Maintain process equipment in validated state; Lead investigations of deviations and implement CAPAs; Develop equipment reliability and maintenance strategies; Partner with Operations, Quality, Validation, and MS&T; Establish equipment specifications; Serve as SME during FDA inspections; Mentor junior engineers
Seniority
Senior, hands-on IC
