Principal Process Engineer
Job in
Greenville, Pitt County, North Carolina, 27834, USA
Listed on 2026-07-14
Listing for:
United Pharma
Full Time
position Listed on 2026-07-14
Job specializations:
-
Engineering
Process Engineer, Validation Engineer, Quality Engineering
Job Description & How to Apply Below
Role :
Principal Process Engineer – Biologics Manufacturing
Location:
North Carolina (Onsite)
Employment Type:
Contract (W2)
Duration : 12+month
We're looking for experienced Principal Process Engineers to support a large-scale greenfield biologics manufacturing project in the Raleigh-Durham area. This is a hands‑on engineering role where you'll serve as the Process System Owner (SME), driving system design, implementation, startup, and operational excellence across critical manufacturing systems.
Key Responsibilities- Serve as the Process System Owner (SME) for assigned manufacturing systems.
- Lead process design, URS/FRS development, and technical decision‑making.
- Partner with A&E firms, EPCM teams, and equipment vendors throughout design, construction, and startup.
- Support equipment selection, system integration, commissioning, and operational readiness.
- Troubleshoot complex process systems and provide technical support during startup.
- Drive technology transfer and process optimization initiatives.
- Collaborate with Manufacturing, Quality, Automation, Engineering, and Validation teams.
- Support risk assessments, deviation investigations, and continuous improvement activities.
- Ensure compliance with GMP and regulatory requirements while contributing to a "Right First Time" startup strategy.
- Bachelor's degree in Engineering or a related discipline.
- 5+ years of Process Engineering experience in a GMP-regulated pharmaceutical or biotechnology environment.
- Strong experience as a Process System Owner with end-to‑end engineering responsibility.
- Experience troubleshooting complex manufacturing systems and translating design concepts into technical requirements.
- Experience supporting greenfield, brownfield, or large‑scale capital projects.
- Hands‑on experience with Emerson DeltaV or similar DCS platforms.
- Clean Utilities: PW, WFI, Clean Steam, Utility Distribution Systems
- Process Support: CIP Systems, Valve Arrays, In-Line Dilution Skids, Caustic Systems, Process Gases
- Upstream: Bioreactors, Seed Train, Cell Culture Systems
- Downstream: Chromatography, Depth Filtration, Nanofiltration, Purification Systems
- Equipment: GMP Washers, Autoclaves, Freezers, Cold Rooms
- Master's, MBA, or PhD in Engineering or a related field.
- Lean Manufacturing and/or Six Sigma experience.
- Experience supporting biologics manufacturing facilities and large‑scale capital projects.
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