Senior Process Engineer - CIP​/SIP​/Autoclaves

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.

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.

This role will develop domainexpertiseand system ownership to supportprocessoperations, focusing onCIP, SIP and Autoclave engineering and plant equipment.

Demonstrate technical expertise and provide lifecycle support for CIP skid systems, SIP circuits, autoclaves, transfer panels, process tanks, valves, instrumentation, and associated automation platforms. The role will support commissioning, qualification, startup readiness, routine manufacturing operations, troubleshooting, requalification and continuous improvement initiatives with a focus on CIP, SIP and autoclave systems.

• Support thedesign andbuildof manufacturingequipmentsystems byaligningdesign reviewprocessesand documents with site requirements, including equipment design and sizing, architecture and electrical distribution, and piping and instrumentation diagrams.
• Supportfactoryacceptancetestingworking in partnership with global engineeringduringsiteinstallation,including reviewing protocolsandresolving punch list items.
• Work withcapitalproject teamto ensure systems are installed andoperatingsafelyandcomply with pertinent environmental health/safety practice,rulesand regulations as well as Amgen global engineering requirements.
  
  Ensure that systems are installed per the design requirements.
• Execute and guidethe commissioning and validation of systemsto ensure their operational capability is alignedwithmanufacturing requirements andGMPregulationand on-time project delivery.
  
  Support execution of engineering and performance qualification runswhile providing hypercaresupport as needed.
• Perform engineering assessments for plant equipment operations,implementing equipment modifications, and supporting engineering runsin support of new product/technology introductions as required.

• Responsible system ownerforCIP, SIP and Autoclave Drug substance process equipment, areas, and systems providing end-to-end support for…