Process / Equipment Engineer โ Downstream Biologics Startup
Location: Holly Springs, NC
Schedule: 100% onsite, MondayโFriday
Contract: 12+ months, strong extension potential
A growing biopharmaceutical manufacturing organization is seeking Process / Equipment Engineers to support the startup of a large-scale greenfield drug substance manufacturing facility in Holly Springs, NC.
These are field-focused roles supporting downstream process equipment installation, commissioning, startup, and early operations. The project is currently in the equipment installation / commissioning phase, with FATs complete and systems being installed onsite.
We are hiring across three downstream equipment areas:
โข Buffer & Product Hold Systems
โข Chromatography Skids
โข UF/DF / TFF Systems
What You'll Do:
โข Serve as system owner for assigned downstream process equipment
โข Perform P&ID walkdowns and redline discrepancies in the field
โข Verify installed equipment, piping, and utility tie-ins against design documents
โข Review equipment installation against P&IDs, piping specs, submittals, and 3D models
โข Coordinate with vendors, construction teams, CQV, operations, and QA
โข Support commissioning, startup, deviations, investigations, CAPAs, and risk assessments
โข Assist with LOTO identification and campaign changeover strategy
Ideal Background:
โข 3โ8 years of GMP biopharma engineering experience
โข Hands-on downstream stainless-steel process equipment experience
โข Exposure to buffer/product hold tanks, chromatography skids, or UF/DF/TFF systems
โข Field/startup experience with P&ID walkdowns, redlines, and installation verification
โข Experience with Navisworks or similar 3D model review tools
โข BS in Chemical Engineering, Biochemical Engineering, Process Engineering, or related discipline
This is a strong opportunity for a mid-level engineer who enjoys being in the field, working closely with equipment and systems, and supporting a major biologics facility from installation through startup.
Interested candidates can message me directly or send a resume for consideration.