Engineering
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.
SeniorProcess Engineer
What you will do
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 ownershipto supportprocessoperations, focusing onUpstream andDownstreamProcess engineering and plant equipment
Site design, construction, start-up, and operational readiness:
Support thedesign andbuildof manufacturingequipmentsystems byaligningdesign reviewprocessesand documentswith site requirements, including equipment design and sizing, architecture and electricaldistribution, and piping and instrumentation diagrams.
Supportfactoryacceptancetestingworking in partnershipwith global engineeringduringsiteinstallation,including reviewing protocolsandresolving punch list items
Work withcapitalproject teamto ensure systems are installed andoperatingsafelyandcomply withpertinent environmental health/safety practice,rulesand regulationsas well as Amgen global engineering requirementsEnsurethat systems are installed per the designrequirements
Executeand guidethe commissioning and validationof systemsto ensure their operational capabilityis alignedwithmanufacturing requirements andGMPregulationand on-time project delivery.Supportexecution of engineering and performance qualification runswhile providinghypercaresupport as needed.
Perform engineering assessmentsfor plant equipment operations,implementing equipment modifications, and supporting engineering runsin support of new product/technology introductions asrequired
Site Operations:
Responsible system ownerforUpstreamandDownstreamDrug substanceprocess equipment, areas, and systems providingend-to-endsupport 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 equipmentas applicable
Leadidentifyingand implementing engineering-based improvements or upgrades toprocessequipmentsystems.This may include developing business cases for improvements,identifyingdesign requirements, and translating these requirements intoprocessequipment/system design, specifications, and supporting the construction, startup, and validation of equipment.
Developmastermaintenance programsfor equipment, ensure the availability of spare parts, andcoordinate 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
Providetechnical masteryandproblem-solvingleadershiptoproactivelyreduce production downtime. Thisincludes leadingtechnical root cause analysis and implementation of corrective/preventiveactions 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 ensure24x7 day-to-dayreliability ofUpstream andDownstream systemsfor plant operations.
Up to10% 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 weseekenjoys challenges and is motivated to help serve patients with these qualifications.
Basic 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
Preferred Qualifications:
Bachelor’s degree in Chemical or Mechanical Engineering
6+years'of relevant work experience with 5+ years' experience in Biopharmaceuticaloperations/manufacturing environment
Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Productionfacility equipment/systemswith direct experience withUpstream and Downstreampurification equipment suchascell culture reactors, centrifugation, chromatography,viralfiltration skids,andUFDFskidsas well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
Experience with Tech Transfer, Process Design, and Commissioning & Qualification.
Experience working in a regulated environment (e.g.cGMP, OSHA, EPA, etc.) andfamiliarity with GMP quality systems/processes such as change control, non-conformances,corrective and preventative actions, and qualifications/validation
Understanding ofsafety requirements working in a GMP Biopharmaceuticalproductionfacility.
Independent, ambitious, organized, able to multi-task in project environments, and skilled incommunication, facilitation, and teamwork
Strong leadership, technical writing, and communication/presentation skills
Work schedule flexibility asrequiredto support 24/7 operations
Ability for domestic/international travel
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Salary Range
115,494.60USD -156,257.40 USD
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We helped establish the biotechnology industry, and we remain on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
Amgen is one of 30 companies comprising the Dow Jones Industrial Average®, and part of the Nasdaq-100 Index®. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes.
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