Principal Process Engineer  - Upstream/Downstream

Career Category

Job Description

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.

PrincipalProcessEngineer - Upstream/Downstream 

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.You willlead technical projects, and drive innovation in product design and manufacturing processes. You will solve complex engineering problems,optimize processes, and ensure the company's engineering efforts align with strategicobjectives. You will also provide leadership and guidance to the engineering team supporting 24/7 manufacturing and facility operations. 

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

• Support thedesign andbuildof manufacturingequipment systems byaligning design review processes and documentswith site requirements, including equipment design and sizing, architecture and electricaldistribution, and piping and instrumentation diagrams.  

• Supportfactoryacceptancetesting working in partnership with global engineering during siteinstallation,including reviewing protocols andresolving punch list items.  

• Work withcapital project team to ensure systems are installed andoperatingsafely andcomply with pertinent environmental health/safety practice,rules and regulations as well as Amgen global engineering requirements.Ensure that systems are installed per the designrequirements.  

• Execute and guide the commissioning and validation of systems to ensure their operational capabilityis aligned withmanufacturing requirements andGMPregulation and on-time project delivery. Support execution of engineering and performance qualification runswhile providinghypercare support as needed. 

• Perform engineering assessments for plant equipment operations,implementing equipment modifications, and supporting engineering runs in support of new product/technology introductions asrequired. 

• Site Operations: 

• Provide system ownershipforUpstream and/orDownstreamDrug substanceprocess equipment, areas, and systems providingend-to-end support for operations. 

• Serve asa main point of contact forProcess and equipment engineering function. 

• 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. 

• Leadidentifying and implementing engineering-based improvements or upgrades toprocessequipmentsystems.This may include developing business cases for improvements,identifying design requirements, and translating these requirements intoprocess equipment/system design, specifications, and supporting the construction, startup, and validation of equipment. 

• Developmaster maintenance programs for 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 theprocess equipment.  

• Providetechnical masteryandproblem-solvingleadershiptoproactivelyreduce production downtime. Thisincludes leading technical root cause analysis and implementation of corrective/preventiveactions for families of systems. 

• Lead new product/technology introductions by performing engineering assessments,equipment performance risk assessments,identifying gaps and owning their remediation,implementing equipment modifications, and supporting engineering runs. 

• Provide mentorship and coaching to junior engineering peers when theyencounter challenges and roadblocks, asappropriate. 

• Demonstrate knowledge and understanding of how building and process automation systems interact with and impact processequipment and be able to effectively communicate automation issues and needs to support groupsand to management. 

• Effectively communicate the correct level of detail for process risksin a timely manner to support groups and leadership. 

• Provide rotational on-call support and ensure 24x7 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 weseek enjoys challenges and is motivated to help serve patients with these qualifications. 

Basic Qualifications: 

• Doctorate degree and 2 years of engineering experience   

OR   

• Master’s degree and 4 years of engineering experience   

OR   

• Bachelor’s degree and 6 years of engineering experience   

OR   

• Associate’s degree and 10 years of engineering experience   

Or  

• High school diploma / GED and 12 years of engineering experience   

And  

• 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources   

Preferred Qualifications: 

• Bachelor’s degree in Chemical or Mechanical Engineering or related technicalfield.. 

• 8+years' of relevant work experience with5+ years' experience in Biopharmaceuticaloperations/manufacturing environment focused on process and plant engineering function. 

• Demonstrated people and/or project management and leadership experience. 

• Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Productionfacility equipment/systemswith direct experience with Upstreamand  Downstream purification equipment such ascell 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 designing and operating equipment used in biopharmaceutical manufacturing. 

• Experience with Tech Transfer, Process Design, and Commissioning & Qualification. 

• Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) andwith GMP quality systems/processes such as change control, non-conformances,corrective and preventative actions, and qualifications/validation 

• Understanding of safety 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 asrequired to support 24/7 operations. 

• Ability for domestic/international travel. 

Salary Range