Sr. Engineer, ARI Engineering Projects

Sr Engineer, ARI Engineering Projects

Let’s do this. Let’s change the world. 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.

The successful candidate will provide engineering leadership for complex process systems supporting both stainless steel and single-use manufacturing technologies within a dynamic commercial manufacturing environment.

• Provide technical expertise in the design and integration of upstream and downstream process equipment including:

  • Bioreactors and cell culture systems

  • Centrifugation systems

  • Chromatography skids

  • UFDF systems

  • Buffer and media preparation systems

  • CIP/SIP systems

  • Single-use technologies

• Lead troubleshooting and technical investigations related to process equipment, automation interactions, and operational performance.

• Support design, construction, startup, commissioning, and qualification of new manufacturing equipment and facility modifications.

• Review and approve engineering deliverables including but not limited to:

  • P&IDs

  • Equipment specifications

  • Functional requirements

  • Highlighted Flow Paths

  • Design reviews

  • FAT/SAT protocols

  • Automation Design Specifications

  • 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.

• 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

  • Regulatory expectations

• Support execution and review of:

  • IQ/OQ/PQ protocols

  • Engineering test runs

  • Risk assessments

  • Change controls

  • Deviations and CAPAs

• 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.

• Collaborate closely with:

  • Manufacturing

  • Process Development

  • Quality

  • Maintenance

  • Automation

  • 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 all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a self-starter with these qualifications.

• High school diploma / GED and 10 years of Engineering experience OR

• Associate’s degree and 8 years of Engineering experience OR

• Bachelor’s degree and 4 years of Engineering experience OR

• Master’s degree and 2 years of Engineering experience OR

• 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 including:

  • Bioreactors

  • Centrifuges

  • Chromatography systems

  • UFDF skids

  • Single-use systems

  • CIP/…