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 as well as developing domain expertise tosupport operations upon start-up.

• Support the commissioning and qualification ofmanufacturingsystems in alignment with GMP requirements and interact with regulatory inspectors.
• Ensuresystemsare installed andoperatesafelyandcomply withpertinent environmental health/safetypractice,rulesand regulations.
• Support commissioning and qualification of systemsto ensure their operational capabilityis alignedwithmanufacturing requirements andGMPregulations.
• Interact with regulatory inspectorsas a manufacturing systems owner to communicate anddemonstrateappropriate regulatorycomplianceofoperating systems.
• Assistwithnew product/technology introductions by performing engineering assessments,implementing equipment modifications, and supporting engineering runs.

• Provide systemsupportforbiopharmaceutical process equipment.
  
  Assistinidentifyingand implementing engineering-based improvements or upgrades to equipment or facility systems.
• Support the developmentofbusiness cases for improvements,identification ofdesign requirements, and translation ofthese 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, andcoordinatemaintenance activities to ensure systems are in proper working order.
• Providesystem guidance toidentifyperformance risks and implement risk reduction strategies.
• Provide problem solving support to reduce production downtime. Thisincludessupporting technical root cause analysis and implementation of corrective/preventiveaction.
• Provide rotational on-call support and/or shift support based on business needstoensure
  24x7 day-to-dayreliability of Solution Prep,Upstream and Downstream systems for plant operations.
• On-site and up to 10% domestic/international travel.

We are all different, yet we all use our unique contributions to serve patients. The engineering professional weseekenjoys challenges and is motivated to help serve patients with these qualifications.

Masters degree

OR

Bachelors degree and 2 years of Engineering experience

OR

Associates degree and 6 years of Engineering experience

OR

High school diploma / GED and 8 years of Engineering experience

• Bachelors degree in Chemical or Mechanical Engineeringor similarengineerdiscipline.
• 3+years'of relevant work experience with2+ years' experience in Biopharmaceuticaloperations/manufacturing environment
• Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems with direct experience with Solution Prep, Upstream, and Downstream purification equipment such as weigh and dispense equipment, solution preparation vessels, cell culture reactors, centrifugation, chromatography, viral filtration skids, and UFDF skids 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…