Senior Manufacturing Systems Engineer

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel likeyou’repart of something bigger,it’sbecause you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980,we’vehelped 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’llhelp 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 thatliewithin them,you’llthrive 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 AmgenFleXBatch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. TheFleXBatch 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.

Senior Manufacturing Systems Engineer:Automation

What you will do

Let’sdo this.Let’schange the world.AsaSeniorManufacturing SystemsEngineer,you will provide automation technical leadership to a group ofautomationengineerswhoare responsible forbuilding andmaintainingvarious automation systems and platforms that support the GMP Drug Substance Plant Operations. 

In this vital role as a member of the Facilities & Engineering (F&E) Automationteam you will work hand in hand with the capital project team to deliver robustprocessautomation systemstooperatethe new plant. 

Sitedesign,construction, start-up, and operational readiness

• Collaborate with key stakeholdersand end-usersto understandand synthesizekey process requirements,and to develop solutions using Amgen standard automation platform forprocessautomation systems

• Support design phases to ensuredesignalignswith Amgen specifications, incorporates the latesttechnology,and meets safety requirements

• Supportvendor FATtoensure that control strategy and software code meet Amgen requirements

• Develop andmaintainengineering and maintenance documentation,and associated procedures for delivered solutions and processes

• Collaborate with cross-functional teams to develop a robust commissioning and qualification plan and/or qualification strategy

• Support commissioning and qualification including Automation Installation Verification/Automation Check Out (IV/ACO)

• SupportQA partnersin performingcomputerized systems validation in aGxPenvironment

• Perform Data Integrity Assessments (DIA)in accordancewiththe current Amgen and industry standards

Site Operations

• Own and driveto completion Change Controls, CAPAs, and Deviations

• Leadandsupport technical root cause analysis, incident investigations, and troubleshooting

• Lead and support functional area projects focused on improving process equipment,utilities,andfacilities as well as large capital projects to integrate new drug substance manufacturing technologies into the facility

• Drive continuous improvement forprocess automation systemsto improve operational workflows, safety, reliability,efficiency,and sustainability

• Supportday-to-dayoperationsincluding rotational on-callsupport

• Perform andmaintainDataIntegrityAssessments(DIA)in accordance withthe current Amgenand industrystandards

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What we expectfromyou

We are all different, yet we all use our unique contributions to serve patients. The automation professional weseekis an engineer with these qualifications:

Basic Qualifications

• High Schooldiploma/GED and10years ofengineering experience OR

• Associate’sdegree and8years ofengineering experience OR

• Bachelor’sdegree and4years ofengineering experience OR

• Master’sdegree and2years ofengineering experience OR

• Doctoratedegree

Preferred Qualifications

• Degree in Electrical Engineering,Computer Science, Chemical Engineering,BiotechEngineering,or related field

• Direct knowledge ofautomationsystemdesign

• Experienceinprogramming,installation and lifecycle management of automation and field instrumentation technologies

• Experience inautomation ofGMP biopharmaceutical equipmentandsystemssuch asbuffer prep and hold,chromatography,single usemixing vessels, depth filtration,andsolution prep

• Experience inintegrating various OEM automation software

• Experiencein programming, design, installation and lifecycle management of manufacturing process controls,andautomation and field instrumentation technologies. 

• Experience with EmersonDeltaVDCS systemandability to perform advanced troubleshooting,andsystemintegration using OPC, Foundation Fieldbus,andProfibustechnologies

• Ability to interpret and apply GAMPs and GMPs,and familiarity with documentation in a highly regulated environmentwith requirements such as 21 CFR Part 11, ASTM 2500, S88 and S95

• Self-directed team playerable to work cross-functionally

• Strong leadership, technicalwriting,and communicationskills

• Ability for domesticand international travel

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What you can expectfromus 

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.From our competitive benefits to our collaborative culture,we’llsupport your journey every step of the way.

In addition to the base salary, Amgen offers a Total Rewards Plan based on eligibility that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Apply nowfor a career that defies imagination

In our quest to serve patientsabove all else, Amgen is the first to imagine and the last to doubt. Join us.

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Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receiveenoughor select a candidate for the position.

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 seriousdisease.

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 areprovided withreasonable accommodation toparticipatein 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.