Process Engineer

ANC2 at Amgen-North Carolina is in the equipment design phase for a large-scale biologics drug substance facility with 5 x 10,000 L bioreactors and 1 downstream purification train. They need a senior process/equipment engineer on the Drug Substance Process Systems / Utilities Engineering team to own a subset of upstream and downstream equipment from design review through mechanical completion and into startup/commissioning and qualification over the next ~2 years. This person must be strong in both process and equipment/automation: able to review and challenge vendor designs (for bioreactors, TFF, chromatography, filtration, large tanks), ensure ASME BPE and hygienic design compliance, work closely with DeltaV automation, and then drive MC, commissioning, and qualification to bring systems online on schedule. This is a hands-on, project-execution role embedded on-site, 100% at ANC, for a 2-year assignment with a bill rate up to $150/hr. 2. Updated Req Story / Context Amgen is expanding its DS manufacturing at the ANC site via the ANC2 Expansion. The facility will include five 10,000 L bioreactors and one downstream purification train, covering both upstream and downstream operations. The ANC2 project is currently in the equipment design phase. This role joins now to: Participate in and lead design reviews for assigned upstream and downstream process systems (e.g., large bioreactors, TFF, chromatography, viral/depth filtration, stainless steel tanks). Translate process requirements (mass balances, process flows, operating ranges) into equipment specs and automation requirements. Ensure designs comply with ASME BPE, hygienic piping, weld and fabrication standards. Drive vendor engagement through design, fabrication, FAT/SAT, and site delivery. Support mechanical completion (MC), field installation, and system walkdowns. Lead or support commissioning and qualification efforts, working with CQV and Automation (DeltaV) from MC to startup and release. Scope and nature of the role: Full lifecycle for assigned systems: design review → MC → C&Q → startup, with emphasis on DS (upstream + downstream). Highly cross-functional, embedded in a large capital project environment. Expectation of some off-hours work around critical tie-ins and startup, but role is fundamentally 100% on-site at ANC. Assignment duration is 2 years, with a bill rate up to $150/hr. This role is ideal for a senior process/equipment engineer who has previously executed major capital projects in biologics (DS) and is comfortable owning critical-path equipment scope for a large-scale facility. 3. NEED TO VALIDATE – Gaps / Open Questions (Refined) Scope & Prioritization For this individual, what is the primary focus: upstream (10kL bioreactors, associated tanks) vs. downstream (purification train – TFF, chromatography, filtration)? Or a true mix of both? Are any specific systems already earmarked for this role (e.g., “own the 10kL bioreactors and associated media/buffer tanks” or “own the full purification skid train”)? Project Details 3. What is the project milestone timeline: expected dates for design freeze, MC, start of commissioning, and facility startup? 4. Is the 2-year assignment expected to cover through PQ/start of commercial operation, or just to mechanical completion and IQ/OQ? Technical / Design Standards 5. Which vendors or platforms are being used for: Bioreactors? TFF? Chromatography? Filtration / tank skids? Are there Amgen-standard design templates or prior facilities this design is being mirrored from (e.g., “copy exact” from another site)? Any specific clean utility interfaces they will touch (CIP, SIP, WFI, clean steam)? Automation / DeltaV 8. How far along is the DeltaV control strategy for these systems—conceptual only, or already partially defined? 9. Do you expect this person to: Primarily define/control requirements and review FDS/SDS? Or also be heavily involved in FAT/SAT with automation and on-site start-up/debug? CQV & MC 10. Will this role author, review, or execute IQ/OQ protocols, or primarily provide technical support to CQV? 11. Do you follow a risk-based/AES/A2500-style CQV model that the candidate should be familiar with? Stakeholders & Decision Rights 12. How much vendor management responsibility will this person have (leading technical meetings, driving issue resolution, etc.)? 13. Will they lead any cross-functional workstreams (e.g., “upstream equipment workstream”) or primarily be an individual contributor inside them? Soft Skills / Culture 14. In this ANC2 project context, what behaviors are absolutely critical (e.g., urgency, documentation rigor, ability to challenge vendors, etc.)? 15. Are you looking for someone more hands-on in the field vs. more documentation/design office–oriented, or both? Logistics / Constraints 16. Any expected off-shift or weekend support around shutdowns/tie-ins for this particular scope? 17. Are you open to non-local candidates if they can relocate and be 100% on-site? 18. Any clearance, background or GMP training requirements that may affect onboarding time? Success Criteria 19. What are the top 3 systems or milestones you’d say this hire will be judged on? (e.g., “shutdown tie-ins for bioreactors”, “C&Q completion of purification train”). 20. What does “success at 12 months” look like in concrete terms? 4. TS Relationship Section (Updated) Customer / Org Team: Drug Substance Process Systems / Utilities Engineering, ANC. Project: ANC2 Expansion – DS facility with 5 x 10kL bioreactors and 1 purification train. Phase: Equipment design now; moving into MC, C&Q, and startup. Key Working Relationships Internal: Process Systems / Utilities Engineering: peers managing other systems; alignment on standards and interfaces. Automation / DeltaV: define and refine control strategies, support FAT/SAT, and startup. CQV: coordinate MC, commissioning/qualification strategy and execution. Manufacturing / Operations: ensure operability and support readiness for operations. Qual