Senior Downstream Process Engineer

Process / Equipment Engineer – Downstream Biologics Startup Location: Holly Springs, NC Schedule: 100% onsite, Monday–Friday Contract: 12+ months, strong extension potentialA 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:• Buffer & Product Hold Systems • Chromatography Skids • UF/DF / TFF SystemsWhat You’ll Do: • Serve as system owner for assigned downstream process equipment • Perform P&ID walkdowns and redline discrepancies in the field • Verify installed equipment, piping, and utility tie-ins against design documents • Review equipment installation against P&IDs, piping specs, submittals, and 3D models • Coordinate with vendors, construction teams, CQV, operations, and QA • Support commissioning, startup, deviations, investigations, CAPAs, and risk assessments • Assist with LOTO identification and campaign changeover strategyIdeal Background: • 3–8 years of GMP biopharma engineering experience • Hands-on downstream stainless-steel process equipment experience • Exposure to buffer/product hold tanks, chromatography skids, or UF/DF/TFF systems • Field/startup experience with P&ID walkdowns, redlines, and installation verification • Experience with Navisworks or similar 3D model review tools • BS in Chemical Engineering, Biochemical Engineering, Process Engineering, or related disciplineThis 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.