Sr Process Engineer Jobs in Angier, NC (NOW HIRING)

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 includefive 10,000 L bioreactorsandone downstream purification train, covering both upstream and downstream operations.

The ANC2 project is currently in theequipment design phase. This role joins now to:

• Participate in and leaddesign reviewsfor 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 withASME BPE, hygienic piping, weld and fabrication standards.

• Drive vendor engagement through design, fabrication, FAT/SAT, and site delivery.

• Supportmechanical completion (MC), field installation, and system walkdowns.

• Lead or supportcommissioning and qualificationefforts, 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 fundamentally100% on-siteat ANC.

• Assignment duration is2 years, with abill 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

1. For this individual, what is theprimary focus: upstream (10kL bioreactors, associated tanks) vs. downstream (purification train – TFF, chromatography, filtration)? Or a true mix of both?

1. Are anyspecific systemsalready earmarked for this role (e.g., “own the 10kL bioreactors and associated media/buffer tanks” or “own the full purification skid train”)?

Project Details3. What is theproject milestone timeline: expected dates for design freeze, MC, start of commissioning, and facility startup? 4. Is the 2-year assignment expected to cover throughPQ/start of commercial operation, or just to mechanical completion and IQ/OQ?

Technical / Design Standards5. Which vendors or platforms are being used for:

• Bioreactors?

• TFF?

• Chromatography?

• Filtration / tank skids?

1. Are thereAmgen-standard design templatesor prior facilities this design is being mirrored from (e.g., “copy exact” from another site)?

1. Any specificclean utilityinterfaces they will touch (CIP, SIP, WFI, clean steam)?

Automation / DeltaV8. How far along is theDeltaVcontrol 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 inFAT/SAT with automationand on-site start-up/debug?

CQV & MC10. Will this roleauthor, review, or executeIQ/OQ protocols, or primarily provide technical support to CQV? 11. Do you follow arisk-based/AES/A2500-styleCQV model that the candidate should be familiar with?

Stakeholders & Decision Rights12. How muchvendor managementresponsibility will this person have (leading technical meetings, driving issue resolution, etc.)? 13. Will they lead anycross-functional workstreams(e.g., “upstream equipment workstream”) or primarily be an individual contributor inside them?

Soft Skills / Culture14. 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 morehands-on in the fieldvs. moredocumentation/design office–oriented, or both?

Logistics / Constraints16. Anyexpected off-shift or weekend supportaround shutdowns/tie-ins for this particular scope? 17. Are you open tonon-local candidatesif they can relocate and be 100% on-site? 18. Anyclearance, backgroundorGMP trainingrequirements that may affect onboarding time?

Success Criteria19. What are thetop 3 systemsor 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: Equipmentdesignnow; 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.

• Quality/Validation: ensure documentation and qualification meet Amgen and regulatory standards.

• External:

• Equipment vendors (bioreactors, TFF, chromatography, filtration, tanks) and integrators.

• Construction contractors and installers for hygienic piping and equipment placement.

How TS Should Position Itself

• As astrategic partnerde-risking schedule and quality for critical upstream and downstream equipment scope on ANC2.

• Emphasize TS focus on:

• Candidates withend-to-end project experience: design reviews → MC → C&Q → startup in large biologics plants.

• Strongdownstream AND upstreamexposure, especially large-scale bioreactors and purification trains.

• Proven ability to interact effectively withDeltaV, vendors, CQV, and operations.

• Commit to:

• Pre-vetting candidates for specificunit operation experience(bioreactors, TFF, chromatography, filtration, tanks).

• Testing candidates on ASME BPE / hygienic design and real-worldshutdown/startupexamples.

• Providing concise, mapped profiles that align each candidate to ANC2’s tangible systems and project phase.

5. Experience – Three Must-Haves (Refined)

1. End-to-end equipment lifecycle for upstream or downstream systems in a biologics DS facility

• Hasled design reviews and supported installationfor one or more of:

• 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.

1. Hands-on commissioning, qualification, and startup in a GMP environment

• Direct involvement frommechanical completion through commissioning & qualification (IQ/OQ, ideally PQ).

• Practical experience working aroundfacility shutdowns, tie-ins, and startup planningfor major process equipment or utility tie-ins.

1. Process + Automation (DeltaV) integration ability

• Strong understanding ofprocess requirements, mass balances, and DS process flows(upstream and/or downstream).

• Demonstrated ability to translate these intoautomation requirementsand to collaborate effectively with aDeltaVteam (URS/FRS, control strategies, interlocks, recipes).

6. Logistics (Updated)

• Location:Amgen-North Carolina (ANC), on-site.

• Work Model:100% on-sitedue to active design, MC, commissioning, and startup needs.

• Duration:2-year assignment.

• Compensation (contract):Bill rateup to $150/hr.

• Schedule:

• Core: Monday–Friday, standard business hours.

• Expectation of someoff-hours/weekend workduring critical shutdowns, tie-ins, or startup activities (need to confirm frequency).

• Travel:Potential travel for vendor FAT/SAT or to other Amgen sites (TBD – clarify with HM).

• Experience/Education:

• Master’s & 6–8 years, OR

• Bachelor’s & 8+ years, OR

• Associate’s & 10+ years engineering (ideally in biopharma/bio-manufacturing).

• Relocation:Not specified—need to confirm if relocation support is possible or if local/commutable is strongly preferred.

7. Req Pitch (Candidate-Facing – Updated)

Amgen is building out its ANC2 drug substance facility in North Carolina, which includes five 10,000 L bioreactors and a full downstream purification train. The project is in the equipment design phase, and they’re looking for a senior process/equipment engineer to join the Drug Substance Process Systems / Utilities Engineering team on a 2-year assignment.

In this role, you’ll own a subset of critical upstream and downstream systems—such as large bioreactors, TFF, chromatography, filtration skids, and stainless steel tanks—throughout the full lifecycle: from design reviews with vendors, through mechanical completion, into commissioning, qualification, and startup.

You will be on-site and in the middle of the action: reviewing vendor designs, ensuring ASME BPE and hygienic standards, collaborating closely with the DeltaV automation team, and working with CQV and operations to safely and efficiently bring the equipment online.

If you’ve previously taken large-scale biologics equipment from design into C&Q in a GMP setting—and you’re comfortable working in the field, managing vendors, and supporting shutdowns and startup—this is a chance to have a direct, visible impact on a flagship biologics expansion, with a competitive bill rate up to $150/hr and clear 2-year project horizon.

8. Sourcing Strategy (Updated for ANC2 Details)

Target Profiles

• Senior engineers withfull lifecycle experiencein:

• Large-scale biologicsupstream(≥5,000 L bioreactors, media/buffer prep).

• Downstreampurification trains (chromatography, TFF, viral/depth filtration).

• Titles:

• Sr Process Engineer / Principal Process Engineer (Biologics)

• Process Equipment Engineer (Upstream/Downstream)

• Capital Projects / Project Engineer – Biotech

• Senior Bioprocess Engineer with facility startup/C&Q experience.

Target Companies

• Large biopharma with big stainless or hybrid DS sites:

• Amgen, Biogen, BMS, Lilly, Merck, J&J, Sanofi, Pfizer, Takeda, Roche/Genentech, AstraZeneca, etc.

• CDMOs and major expansions:

• Lonza, Fujifilm Diosynth, Catalent, Samsung Biologics, WuXi Biologics, Thermo Fisher, etc.

• Skid vendors / integrators:

• Cytiva, Sartorius, Pall, MilliporeSigma, other integrators working on large bioreactors and downstream skids.

Geographic Focus

• Primary:NC (RTP, greater NC area).

• Secondary:East Coast hubs (MA, PA, NJ, MD, GA) – willing to relocate for 100% on-site 2-year project.

• Tertiary:Broader US candidates with recent large-scale (10kL-class) DS expansions.

Search Keywords

• “10,000 L bioreactor” OR “10kL bioreactor” OR “large-scale bioreactor”

• “upstream process equipment” AND (biologics OR mAb)

• “tangential flow filtration” OR “TFF skid”

• “chromatography skid” / “downstream chromatography”

• “viral filtration” / “depth filtration” / “purification train”

• “ASME BPE” AND “hygienic piping”

• “DeltaV” AND (biotech OR biopharma)

• “commissioning and qualification” OR “C&Q” OR “CQV” AND “biologics”

• “mechanical completion” AND “biotech”

• “facility startup” OR “greenfield” OR “capital project” AND “biologics”

Screening Priorities

• Confirm concrete examples:

• Led design review and implementation of at least one: large bioreactor, TFF, chromatography, filtration skid, or large tank system.

• Participated inMC, commissioning and IQ/OQfor those systems.

• Probe depth on:

• ASME BPE, hygienic piping, weld inspection/test experience.

• Interaction withDeltaVteams (how they defined or reviewed control strategies, interlocks, recipes).