Process Engineer
$312,000–$312,000 year
On-siteRaleigh, North Carolina, United States
Job Summary
Lead design reviews for upstream and downstream process systems, including large bioreactors, TFF, chromatography, and filtration skids. Translate process requirements into equipment specs and automation needs while ensuring ASME BPE and hygienic design compliance. Drive vendor engagement through design, fabrication, FAT/SAT, and site delivery. Support mechanical completion, system walkdowns, and commissioning efforts with the DeltaV automation team and CQV. Own a subset of critical equipment from design review through startup and qualification on the ANC2 expansion project. Work 100% on-site at Amgen-North Carolina for a two-year assignment with a bill rate up to $150/hr.
Required Qualifications
- End-to-end equipment lifecycle for upstream or downstream systems in a biologics DS facility
- Has led design reviews and supported installation for large bioreactors (ideally ≥5,000 L), tangential flow filtration, chromatography, viral filtration, depth filtration, large stainless steel tank skids
- Experience reviewing vendor drawings, P&IDs, and specifications with ASME BPE and hygienic piping in mind
- Hands-on commissioning, qualification, and startup in a GMP environment
- Direct involvement from mechanical completion through commissioning & qualification (IQ/OQ, ideally PQ)
- Practical experience working around facility shutdowns, tie-ins, and startup planning for major process equipment or utility tie-ins
- Strong understanding of process requirements, mass balances, and DS process flows (upstream and/or downstream)
- Demonstrated ability to translate these into automation requirements and to collaborate effectively with a DeltaV team (URS/FRS, control strategies, interlocks, recipes)
- Master's & 6–8 years, OR Bachelor's & 8+ years, OR Associate's & 10+ years engineering (ideally in biopharma/bio-manufacturing)
- 100% on-site at Amgen-North Carolina (ANC)
- Some off-hours/weekend work during critical shutdowns, tie-ins, or startup activities
- Potential travel for vendor FAT/SAT or to other Amgen sites
Desired Qualifications
- Experience with large-scale biologics upstream (≥5,000 L bioreactors, media/buffer prep)
- Downstream purification trains (chromatography, TFF, viral/depth filtration)
- Proven ability to interact effectively with DeltaV, vendors, CQV, and operations
- Commitment to pre-vetting candidates for specific unit operation experience (bioreactors, TFF, chromatography, filtration, tanks)
- Testing candidates on ASME BPE / hygienic design and real-world shutdown/startup examples
- Providing concise, mapped profiles that align each candidate to ANC2's tangible systems and project phase
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