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 lie 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.
Senior Manufacturing Systems Engineer :Automation
What you will do
Let's do this. Let's change the world. As a Senior Manufacturing Systems Engineer, you will provide?automation?technical leadership to a group of automation engineers who are responsible for building and maintaining various 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) Automation team?you will work hand in hand with the capital project team to deliver robust process automation systems to operate the new plant.?
Site design, 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 expect from you
We are all different, yet we all use our unique contributions to serve patients. The automation professional we seek is 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 expect from us
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'll support 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 now for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine and the last to doubt. Join us.
careers.amgen.com
AmgenNorthCarolina
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive enough or 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 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 with 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.
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
