Process Engineer - Solution Prep, Upstream, and Downstream

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. 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.

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.

Process Engineer - Solution Prep, Upstream, and Downstream

In this vital role you will be joining the Facilities & Engineering (F&E) group to partner closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production as well as developing domain expertise to support operations upon start - up.

Site design, construction, start-up, and operational readiness:

• Support the commissioning and qualification of manufacturing systems in alignment with GMP requirements and interact with regulatory inspectors.
• Ensure systems are installed and operate safely and comply with pertinent environmental health/safety practice, rules and regulations.
• Support commissioning and qualification of systems to ensure their operational capability is aligned with manufacturing requirements and GMP regulations.
• Interact with regulatory inspectors as a manufacturing systems owner to communicate and demonstrate appropriate regulatory compliance of operating systems.
• Assist with new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.

Site Operations:

• Provide system support for biopharmaceutical process equipment. Assist in identifying and implementing engineering-based improvements or upgrades to equipment or facility systems.
• Support the development of business cases for improvements, identification of design requirements, and translation of these requirements into process equipment/system design, specifications, and supporting the construction, startup, and validation of improvements.
• Develop equipment maintenance programs, ensure the availability of spare parts, and coordinate maintenance activities to ensure systems are in proper working order.
• Provide system guidance to identify performance risks and implement risk reduction strategies.
• Provide problem solving support to reduce production downtime. This includes supporting technical root cause analysis and implementation of corrective/preventive action.
• Provide rotational on-call support and/or shift support based on business needs to ensure 24x7 day-to-day reliability of Solution Prep, Upstream and Downstream systems for plant operations.
• On-site and up to 10% domestic/international travel.

What we expect of you

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.

Basic Qualifications:

Master's degree OR Bachelor's degree and 2 years of Engineering experience OR Associate's degree and 6 years of…