PharmaOn-siteContract
Senior Process Engineer – Downstream
Wilson, NC
Posted Oct 22, 2026
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ROLE OVERVIEW
Seeking an experienced Senior Process Engineer to support the development of a new Greenfield mammalian cell culture drug substance manufacturing facility in Wilson, NC. The role focuses on downstream processing equipment, including UF/DF and chromatography systems, ensuring equipment installation, commissioning readiness, and operational preparedness for large-scale biologics manufacturing.
About the Position
Seeking an experienced Senior Process Engineer to support the development of a new Greenfield mammalian cell culture drug substance manufacturing facility in Wilson, NC. The role focuses on downstream processing equipment, including UF/DF and chromatography systems, ensuring equipment installation, commissioning readiness, and operational preparedness for large-scale biologics manufacturing.
Key Responsibilities
- ✓Serve as system owner for assigned equipment (UF/DF, chromatography systems, buffers, etc.) and process areas within a new Greenfield manufacturing site.
- ✓Oversee vendor interactions, FAT/SAT support, installation, commissioning readiness, and documentation review.
- ✓Ensure equipment is delivered, installed, and tested to support robust qualification and operational readiness.
- ✓Review and approve technical documents, drawings, specifications, and protocols.
- ✓Support process design, troubleshooting, and readiness activities as equipment arrives through July.
- ✓Collaborate with Operations, Validation, Engineering, and Quality to ensure timelines and deliverables are met.
Requirements & Qualifications
- •7+ years experience in biopharma or biotech manufacturing engineering.
- •Strong preference for downstream purification experience; upstream mammalian cell culture experience is also beneficial.
- •Background supporting large-scale biologics facilities, Greenfield projects, or system ownership activities.
- •Ability to operate effectively in a fast-paced construction/startup environment.
Direct Application
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