Senior Process Engineer

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At Amgen, if you feel like you are 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. 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 lie within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgen’s newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless‑steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best‑in‑class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen’s plan to be a carbon‑neutral company by 2027.

• Provide system ownership for biopharmaceutical process equipment. Identify, support, and/or lead implementation of engineering‑based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.
• Develop equipment maintenance programs, ensure the availability of spare parts, and coordinate maintenance activities to ensure systems are in proper working order.
• Ensure systems are installed and operating safely and stay in sync with pertinent environmental health/safety practice, rules and regulations.
• Ensure commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors.
• Guide system performance risk identification and implement risk reduction strategies.
• Provide problem‑solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.
• Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.

We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek enjoys challenges and is motivated to help serve patients 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

• Bachelor’s degree in Chemical or Mechanical Engineering
• 6+ years’ of relevant work experience with 5+ years’ experience in biopharmaceutical operations/manufacturing environment with a focus on upstream unit operations
• Direct knowledge of design and troubleshooting with GMP biopharmaceutical production facility equipment/systems such as cell culture reactors, centrifugation, chromatography, tangential flow filtration as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
• Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data‑driven techniques and analyses (e.g.,…