Manufacturing Systems Engineer: Automation - Delta V

Amgen SA; Holly Springs (NC); On-site; USD 95,000 - 130,000; Full time

Job summary

Amgen in North Carolina is hiring a Manufacturing Systems Engineer: Automation- DeltaV to build and maintain automation systems supporting the new drug substance plant.

You will collaborate with the Facilities & Engineering Automation team, contribute to validation, change controls, and continuous improvement, with focus on leveraging Emerson DeltaV and GMP-compliant processes.

Qualifications

• High School Diploma / GED with 8 years engineering experience.
• Associate’s Degree with 6 years engineering experience.
• Bachelor’s Degree with 2 years engineering experience.
• Master’s Degree in a relevant engineering field.

Responsibilities

• Develop and maintain the DeltaV DCS process control system.
• Collaborate with stakeholders to implement automation solutions.
• Provide documentation for delivered solutions and processes.
• Support QA in computerized systems validation (GxP).
• Drive continuous improvement for automation systems.

Skills

DeltaV DCS

Automation engineering

GxP awareness

Technical writing

Education

Bachelor’s Degree

Tools

Emerson DeltaV

OPC

Foundation Fieldbus

Profibus

Job description

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.

Manufacturing SystemsEngineer:Automation- Delta V

What you will do

Let’sdo this.Let’schange 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 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 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

• Associate’s Degreeand 6 years of Engineering experience OR

• Bachelor’s Degree and 2 years of Engineering experience OR

• Master’s 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,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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