Manufacturing Systems Engineer Automation Delta V

Join Amgens Mission of Serving Patients

At Amgen if you feel likeyourepart of something biggeritsbecause you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980wevehelped 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 teamyoullhelp 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 themyoullthrive 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 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 Amgens plan to be a carbon-neutral company by 2027.

Manufacturing SystemsEngineer:Automation- Delta V

What you will do

Letsdo the aManufacturing SystemsEngineeryou 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 robustprocess 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 equipmentutilitiesandfacilities 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 EngineeringComputer Science Chemical EngineeringBiotech Engineeringor 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 bioreactorssolution prepsingle use mixingvesselschromatographyTFFL/TFFXviral filtration viral inactivationUF/DFdepth filtration drug substance fillCIP/SIP clean utilitiesand integrating various OEM automation software.

• Experienceinprogramminginstallationand lifecycle management of automation and field instrumentation technologies.

• Experiencein programming design installation and lifecycle management of manufacturing process controlsandautomation and field instrumentation technologies.

• Experience with EmersonDeltaVDCS systemandability to perform advanced troubleshootingand systemintegration using OPC Foundation FieldbusandProfibustechnologies.

• Ability to interpret and apply GAMPs and GMPsand 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 our competitive benefits to our collaborative culturewellsupport 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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Salary Range