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

1. 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?

1. 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?

1. Are there Amgen-standard design templates or prior facilities this design is being mirrored from (e.g., "copy exact" from another site)?

1. 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.

• 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 a strategic partner de-risking schedule and quality for critical upstream and downstream equipment scope on ANC2.

• Emphasize TS focus on:

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

• Strong downstream AND upstream exposure, especially large-scale bioreactors and purification trains.

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

• Commit 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.

5. Experience - Three Must-Haves (Refined)

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

• Has led design reviews and supported installation for 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 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.

1. Process + Automation (DeltaV) integration ability

• 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).

6. Logistics (Updated)

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

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

• Duration: 2-year assignment.

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

• Schedule:

• Core: Monday-Friday, standard business hours.

• Expectation of some off-hours/weekend work during 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 with full lifecycle experience in:

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

• Downstream purification 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 in MC, commissioning and IQ/OQ for those systems.

• Probe depth on:

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

• Interaction with DeltaV teams (how they defined or reviewed control strategies, interlocks, recipes).

• Past shutdown/tie-in planning and execution.

• Confirm willingness and ability to:

• Be 100% on-site in NC.

• Commit to a 2-year assignment.

• Work some off-shift/weekend as project dictates.

9. Questions to Ask During the Intake Call (Refined)


Project & Scope

1. For this hire, will the main focus be upstream equipment (10kL bioreactors, media/buffer tanks), downstream purification train, or an intentional mix of both?

1. Which specific systems do you foresee assigning to this person (e.g., "one or more bioreactors plus associated tanks", "full purification skid train", etc.)?

1. Where exactly are you now in the design phase (basic vs. detailed), and what are the upcoming 6-12 month milestones for their scope?

Technical Expectations 4. Of the systems listed in the JD (TFF, chromatography, viral filtration, depth filtration, large tanks), which are non-negotiable for prior experience vs. "nice-to-have"? 5. How important is prior large-scale (≥10kL) upstream experience vs. smaller scale? 6. Which vendors/platforms are being used for the bioreactors and purification skids, and do you prefer candidates with experience on those specific platforms? 7. How deep should their knowledge of ASME BPE and hygienic piping be-must they be able to challenge vendors on weld and fabrication details, or is a working understanding enough?


Automation & CQV 8. What is the current status of DeltaV design for these systems, and what do you expect this person to own (requirements, review, FAT/SAT support, startup/debug)? 9. To what extent will they author vs. review URS/FRS/DS and IQ/OQ protocols? 10. Describe your CQV and MC approach for ANC2. Are there any internal standards or methodologies they must be familiar with?


Workstyle & Responsibilities 11. How much time will be spent in design meetings vs. in the field on MC, walkdowns, and troubleshooting during execution? 12. How much vendor management do you expect from this engineer (leading technical calls, driving issue closure, tracking actions)? 13. Will they be expected to lead cross-functional meetings or workstreams, or act primarily as a strong individual contributor?


Schedule & Logistics 14. How often do you anticipate off-shift/weekend work for this role, particularly around shutdowns, tie-ins, and startup? 15. Are you open to relocating a strong candidate from outside NC if they can be 100% on-site? 16. Is there any travel expected for FAT/SAT or cross-site meetings?


Success & Fit 17. What are the top three outcomes you want this person to achieve in the first 12 months (e.g., C&Q complete for specific systems)? 18. How will you measure success at 3, 6, and 12 months for this role? 19. What characteristics have made engineers on this project particularly successful so far (e.g., proactive communication, ability to challenge vendors, documentation rigor)? 20. Are there any backgrounds or company types you especially value-or that have not worked well-for similar roles on ANC2?


Skills and Requirements - add details here