Manufacturing SystemsEngineer:

Automation

• Delta V Employer Amgen Location Holly Springs, North Carolina Start date Jul 15, 2026 View more categories View less categories Discipline Engineering , Automation Engineer , Manufacturing & Production Required Education High School or equivalent Position Type Full time Hotbed Best Places to Work Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job.

Send job Job Details Company Job Details Join Amgens Mission of Serving Patients At Amgen, if you feel likeyourepart of something bigger,itsbecause you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980,wevehelped 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,youllhelp 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,youllthrive 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.

Manufacturing SystemsEngineer:

Automation

• Delta V What you will do Letsdo this.

Letschange the world.

As aManufacturing SystemsEngineer,you willwork with agroup ofautomationengineers whoare responsibleforbuildingandmaintainingvarious automation systems and platforms that support the GMP DrugSubstancePlant Operations. In this vital roleas a member of the Facilities & Engineering (F&E) Automationteamyou will work hand in hand with the capital project team to deliver robust process automation systemstooperatethe new plant.

Responsibilities:

Develop andmaintainthe process control system on EmersonDeltaVdistributed control system (DCS). Collaborate with key stakeholders and end-users to understand and synthesize key process requirements, and to develop solutions using Amgen standard automation platform for process automation systems. Provide clear documentation for delivered solutions andprocesses. Support QA partners in performing computerized systems validation in aGxPenvironment. Perform Data Integrity Assessments (DIA)in accordance withthe current Amgen and industry standards. Supportprocess automationsystemsto ensure design aligns with Amgen specifications, incorporates the latest technology, and meets safety requirements. Support vendor FAT to ensure that control strategy and software code meet Amgen requirements. Develop andmaintainengineering and maintenance documentation, and associated procedures for delivered solutions and processes. Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO) in a fast-paced environment. Site Operations Own and drivetocompletionChange Controls, CAPAs, and Deviations. Supporttechnical root cause analysis, incident investigations, and troubleshooting. 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. Prepare/review Standard Operating Procedures (SOP) and cGMP documents. Be constantly curious and feed your passion and interests in groundbreaking technology. Use your given time to look for new and innovative ways to do business differently, better, and more cost effectively. 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 School Diploma / GED and 8 years of Engineering experience OR Associates Degreeand 6 years of Engineering experience OR Bachelors Degree and 2 years of Engineering experience OR Masters Degree Preferred Qualifications Degree in Electrical Engineering,Computer Science, Chemical Engineering,Biotech Engineering,or relatedfield. Direct knowledge of Automation System design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation such as media, harvest, bioreactors,solution prep,single use mixingvessels,chromatography,TFFL/TFFX,viral filtration, viral inactivation,UF/DF,depth filtration, drug substance fill,CIP/SIP, clean utilities,and integrating various OEM automation software. Experienceinprogramming,installation,and lifecycle management of automation and field instrumentation technologies. Experiencein programming, design, installation and lifecycle management of manufacturing process controls,andautomation and field instrumentation technologies. Experience with EmersonDeltaVDCS systemandability to perform advanced troubleshooting,and systemintegration 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 technical writing and communicationskills. 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,wellsupport 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. careers.amgen.com #AmgenNorthCarolina Company We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world's leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide. We live the mission. We win together. We thrive on continual challenge. Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission. At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we're transforming the promise of science and biotechnology into therapies that have the power to restore health. Connect with us to explore how you can Win, Live, and Thrive at Amgen.

Company info Website http:

//careers.amgen.com/ Phone 805-447-1000 Location Corporate Headquarters One Amgen Center Drive Thousand Oaks California 91320-1799 United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert Similar jobs Engineer III, Electrical Norwood, Massachusetts Manufacturing Specialist

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