Senior Process Engineer CIPSIPAutoclaves

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 illnessesdrives 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 Amgens 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 Amgens 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 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 engineeringduringsiteinstallationincluding reviewing protocolsandresolving punch list items.
• Work withcapitalproject teamto ensure systems are installed andoperatingsafelyandcomply withpertinent environmental health/safety practicerulesand regulationsas well as Amgen global engineering systems are installed per the designrequirements.
• Executeand guidethe commissioning and validationof systemsto ensure their operational capabilityis alignedwithmanufacturing requirements andGMPregulationand on-time project of engineering and performance qualification runswhile providinghypercaresupport as needed.
• Perform engineering assessmentsfor plant equipment operationsimplementing 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( 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 may include developing business cases for improvementsidentifyingdesign 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 assessmentsequipment performance risk assessmentsidentifyinggaps and owning their remediationimplementing 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
• Mastersdegree and 2 years of Engineering experienceOR
• Bachelorsdegree and4years ofEngineeringexperienceOR
• Associatesdegree and8years ofEngineeringexperienceOR
• High school diploma / GED and10years ofEngineeringexperience

Preferred Qualifications:

• Degree in Chemical or Mechanical Engineeringor similar engineering discipline.
• 6yearsof 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 PrepUpstreamandDownstreampurification equipment suchasweigh and dispense equipment solution preparation vesselscell culture reactors centrifugation chromatographyviralfiltration skidsandUFDFskidsas 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 ( OSHA EPA etc.) andfamiliarity with GMP quality systems/processes such as change control non-conformancescorrective 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.

Salary Range