Sr Engineer, ARI Engineering Projects

What you will do

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.

Responsibilities include:

Process Equipment & System Ownership

• 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.

Project Engineering & Capital Delivery

• 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.

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

  • 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

  • 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.

What we expect of you

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.

Basic 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

Preferred Qualifications

• 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/SIP systems

• Experience with:

  • Commissioning & Qualification (C&Q)

  • Capital project execution

  • Lifecycle Management Projects

  • Process troubleshooting

  • Operational readiness

  • Manufacturing support

• Knowledge of GMP quality systems including:

  • Change controls

  • Deviations

  • CAPAs

  • Risk assessments

  • Validation documentation

• Experience working with DeltaV and process automation systems preferred

• Strong technical problem-solving and communication skills

• Ability to lead cross-functional initiatives in a fast-paced manufacturing environment

• Experience balancing operational support with project execution and continuous improvement initiatives

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans

• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship for this role is not guaranteed.

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Salary Range