Senior Process Engineer - Solution Prep, Upstream, and Downstream

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnesses drives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll 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 on Solution Prep,Upstream,andDownstream

Process engineering and plant equipment.

• 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.
• Executeand guidethe commissioning and validation of systemsto ensure their operational capability is alignedwithmanufacturing requirements andGMPregulationand on-time project delivery.
  
  Supportexecution of engineering and performance qualification runswhile providinghypercaresupport 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 ownerfor
  
  Solution Prep,Upstream,andDownstream
  
  Drug substanceprocess equipment, areas, and systems providingend-to-end support for operations.
• Effectively collaborate with key customers and support groups(e.g.Manufacturing, Quality, Process Development, Maintenance, network partners) to ensure reliable plant operations.
• Work with original equipment manufacturers for breakdown and planned maintenance ofprocess equipment as applicable.
• Leadidentifyingand implementing engineering-based improvements or upgrades toprocessequipmentsystems.
  
  This may include developing business cases for improvements,identifyingdesign requirements, and translating these requiredintoprocessequipment/system design, specifications, and supporting the construction, startup, and validation of equipment.
• Developmastermaintenance programs for equipment, ensure the availability of spare parts, and coordinate maintenance activities to ensure systems are in proper working order.
• Ensure plant readiness and quality and regulatory compliance for internal audits, external agency audits, and partner audits for theprocessequipment.
• Provide technical masteryandproblem-solvingleadershiptoproactivelyreduce production downtime. This includes leading technical root cause analysis and implementation of corrective/preventive actions for families of systems.
• Leadnew product/technology introductions by performing engineering assessments,equipment performance risk assessments,identifyinggaps and owning their remediation,implementing equipment modifications, and supporting engineering runs.
• 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%…