Sr. Engineer, ARI Engineering Projects
About The Position
Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. 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.
Requirements
- 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/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
- 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
Nice To Haves
- Experience working with DeltaV and process automation systems preferred
Responsibilities
- 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.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
