Senior Downstream Process Engineer
Job
Technical Source
Holly Springs, NC (In Person)
Full-Time
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Job Description
Senior Downstream Process Engineer at Technical Source Senior Downstream Process Engineer at Technical Source in holly springs, North Carolina Posted in 4 days ago.
Type:
full-timeJob Description:
Process / Equipment Engineer -Downstream Biologics Startup Location:
Holly Springs, NC Schedule:
100% onsite,Monday-Friday 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:- Buffer & Product Hold Systems
- Chromatography Skids
UF/DF / TFF
Systems What 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 strategy
Ideal 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 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.
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