Process Engineer

• Raleigh
• On-site

Job Description

ANC2 at Amgen-North Carolina is in the equipment design phase for a large-scale biologics drug substance facility with 5 x 10000 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 10000 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 systemsconceptual 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 / 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 officeoriented 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 youd 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 ANC2s 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 5000 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: MondayFriday 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:

• Masters & 68 years OR

• Bachelors & 8 years OR

• Associates & 10 years engineering (ideally in biopharma/bio-manufacturing).

• Relocation:Not specifiedneed 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 10000 L bioreactors and a full downstream purification train. The project is in the equipment design phase and theyre 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 youll own a subset of critical upstream and downstream systemssuch as large bioreactors TFF chromatography filtration skids and stainless steel tanksthroughout 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 youve previously taken large-scale biologics equipment from design into C&Q in a GMP settingand youre comfortable working in the field managing vendors and supporting shutdowns and startupthis 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(5000 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

• 10000 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).

• Pastshutdown/tie-inplanning and execution.

• Confirm willingness and ability to:

• Be100% on-sitein NC.

• Commit to a2-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 beupstream equipment (10kL bioreactors media/buffer tanks)downstream purification train or an intentional mix of both

1. Whichspecific systemsdo 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 thedesign phase(basic vs. detailed) and what are the upcoming 612 month milestones for their scope

Technical Expectations4. Of the systems listed in the JD (TFF chromatography viral filtration depth filtration large tanks) which arenon-negotiablefor prior experience vs. nice-to-have 5. How important is priorlarge-scale (10kL)upstream experience vs. smaller scale 6. Whichvendors/platformsare 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 ofASME BPE and hygienic pipingbemust they be able to challenge vendors on weld and fabrication details or is a working understanding enough

Automation & CQV8. What is the current status ofDeltaVdesign for these systems and what do you expect this person to own (requirements review FAT/SAT support startup/debug) 9. To what extent will theyauthor vs. reviewURS/FRS/DS and IQ/OQ protocols 10. Describe yourCQV and MC approachfor ANC2. Are there any internal standards or methodologies they must be familiar with

Workstyle & Responsibilities11. How muchtime will be spent in design the field on MC walkdowns and troubleshooting during execution 12. How muchvendor managementdo you expect from this engineer (leading technical calls driving issue closure tracking actions) 13. Will they be expected tolead cross-functional meetings or workstreams or act primarily as a strong individual contributor

Schedule & Logistics14. How often do you anticipateoff-shift/weekend workfor this role particularly around shutdowns tie-ins and startup 15. Are you open torelocatinga strong candidate from outside NC if they can be 100% on-site 16. Is there anytravelexpected for FAT/SAT or cross-site meetings

Success & Fit17. What are thetop three outcomesyou want this person to achieve in the first 12 months (e.g. C&Q complete for specific systems) 18. How will you measuresuccess at 3 6 and 12 monthsfor this role 19. What characteristics have made engineers on this project particularlysuccessfulso far (e.g. proactive communication ability to challenge vendors documentation rigor) 20. Are there anybackgrounds or company typesyou especially valueor that have not worked wellfor similar roles on ANC2