Senior Process Engineer - CIP / SIP / Autoclaves

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.

SeniorProcessEngineer-CIP/SIP/Autoclave

What youwill 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 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.

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 requirements.Ensurethat 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 ownerforCIP, SIP and AutoclaveDrug 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.
• Developmaster maintenance 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/or shift support based on business needs to ensure24x7 day-to-dayreliability of Solution Prep, Upstream and Downstream systemsfor plant operations.
• On-site and up to10% domestic/international travel.

What we expectofyou

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:

• Doctorate degreeOR
• Master’sdegree and 2 years of Engineering experienceOR
• Bachelor’sdegree and4years ofEngineeringexperienceOR
• Associate’sdegree and8years ofEngineeringexperienceOR
• High school diploma / GED and10years ofEngineeringexperience

Preferred Qualifications:

• Degree in Chemical or Mechanical Engineeringor similar engineering discipline.
• 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 withSolution Prep,Upstream,andDownstreampurification equipment suchasweigh and dispense equipment, solution preparation vessels,cell 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 limited domestic/international travel.