Sr. Engineer, ARI Engineering Projects

Sr Engineer, ARI Engineering Projects

In this vital role, the Senior Engineer will join the ARI Facilities & Engineering (F&E) organization to provide technical engineering support for commercial biologics manufacturing operations with a focus on upstream and downstream process systems and equipment.

The engineer will serve as a technical lead and interface with A/E firms supporting equipment design, process design, operational readiness, troubleshooting, capital project execution, commissioning & qualification (C&Q), and continuous improvement initiatives across manufacturing operations. This role will partner closely with Manufacturing, Process Development, Quality, Maintenance, Automation, and Capital Projects to ensure safe, compliant, and reliable operation of GMP manufacturing systems.

• Process Equipment & System Ownership
  • Provide technical expertise in the design and integration of upstream and downstream process equipment including bioreactors, cell culture systems, centrifugation systems, chromatography skids, UFDF systems, buffer and media preparation systems, CIP/SIP systems, and single‑use technologies.
  • Lead troubleshooting and technical investigations related to process equipment, automation interactions, and operational performance.
• Project Engineering & Capital Delivery
  • Support design, construction, startup, commissioning, and qualification of new manufacturing equipment and facility modifications.
  • Review and approve engineering deliverables such as P&IDs, equipment specifications, functional requirements, highlighted flow paths, design reviews, FAT/SAT protocols, automation design specifications, and turnover documentation.
  • Partner with Capital Project teams and Engineering Technical Authorities (ETA) to ensure alignment with Amgen standards and manufacturing requirements.
  • Support utility tie‑ins, operational readiness activities, new product introductions, and hyper‑care support following startup.
• Commissioning & Qualification (C&Q)
  • Lead and support commissioning and qualification activities for GMP process systems.
  • Ensure systems are designed, installed, tested, and operated in accordance with GMP requirements, safety standards, site procedures, and regulatory expectations.
  • Support execution and review of IQ/OQ/PQ protocols, engineering test runs, risk assessments, change controls, deviations, and CAPAs.
• Operational Excellence & Continuous Improvement
  • Identify and implement engineering‑based improvements to optimize equipment reliability, throughput, process robustness, and operational efficiency.
  • Lead root cause analysis and implementation of corrective and preventive actions (CAPAs).
  • Support predictive maintenance, reliability initiatives, and process performance monitoring.
  • Utilize engineering and data‑driven tools to improve operational performance and reduce downtime.
• Cross‑Functional Leadership
  • Collaborate closely with Manufacturing, Process Development, Quality, Maintenance, Automation, and EHSS Global Engineering.
  • Mentor junior engineers and support development of engineering best practices across the organization.
  • Drive a culture of safety, accountability, collaboration, and continuous improvement.

We are looking for a self‑starter with the following qualifications:

• High school diploma / GED and 10 years of engineering experience
• Associate’s degree and 8 years of engineering experience
• Bachelor’s degree and 4 years of engineering experience
• Master’s degree and 2 years of engineering experience
• Doctorate degree

• Degree in Chemical Engineering, Mechanical Engineering, Bioprocess Engineering, or related discipline
• Experience supporting GMP biopharmaceutical manufacturing operations
• Direct knowledge of upstream and/or downstream process equipment such as bioreactors, centrifuges, chromatography systems, UFDF skids, single‑use systems, and CIP/SIP systems
• Experience with commissioning & qualification (C&Q) and capital project execution
• Lifecycle management projects, process troubleshooting, operational readiness, and manufacturing support
• Knowledge of GMP quality systems including change controls, deviations, CAPAs, risk…