Manufacturing SystemsEngineer:Automation- Delta V

Manufacturing Systems Engineer:
Automation – Delta V

As a Manufacturing Systems Engineer, you will work with a team of automation engineers responsible for building and maintaining automation systems and platforms that support GMP Drug Substance Plant operations. In this vital role, you will partner closely with the capital project team to deliver robust process automation systems for the new plant.

• Develop and maintain the process control system on Emerson Delta V distributed control system (DCS).
• Collaborate with key stakeholders and end‑users to understand and synthesize process requirements, and develop solutions using the Amgen standard automation platform.
• Provide clear documentation for delivered solutions and processes.
• Support QA partners in performing computerized system validation in a GxP environment.
• Perform Data Integrity Assessments (DIA) in accordance with Amgen and industry standards.
• Support process automation systems to ensure design aligns with Amgen specifications, incorporates the latest technology, and meets safety requirements.
• Support vendor FAT to ensure control strategy and software code meet Amgen requirements.
• Develop and maintain engineering 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 drive completion of Change Controls, CAPAs, and Deviations.
• Support technical root cause analysis, incident investigations, and troubleshooting.
• Support functional area projects focused on improving process equipment, utilities, and facilities, as well as large capital projects.
• Drive continuous improvement for process automation systems to improve operational workflows, safety, reliability, efficiency, and sustainability.
• Support day‑to‑day operations including rotational on‑call support.
• Prepare/review Standard Operating Procedures (SOP) and cGMP documents.
• Be constantly curious and seek innovative ways to improve business processes.

We look for an engineer with the following qualifications.

• High School Diploma / GED and 8 years of Engineering experience OR
• Associate’s Degree and 6 years of Engineering experience OR
• Bachelor’s Degree and 2 years of Engineering experience OR
• Master’s Degree

• Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field.
• Direct knowledge of Automation System design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation (media, harvest, bioreactors, solution prep, single‑use mixing vessels, chromatography, TFF, viral filtration, UF/DF, depth filtration, drug substance fill, CIP/SIP, clean utilities, and integration of OEM automation software).
• Experience in programming, installation, and lifecycle management of automation and field instrumentation technologies.
• Experience with Emerson Delta V DCS system and ability to perform advanced troubleshooting, system integration using OPC, Foundation Fieldbus, and Profinet technologies.
• Ability to interpret and apply GAMPs and GMPs, and familiarity with documentation in a highly regulated environment (21 CFR Part 11, ASTM 2500, S88 and S95).
• Self‑directed team player able to work cross‑functionally.
• Strong technical writing and communication skills.

In addition to competitive compensation, Amgen offers a comprehensive Total Rewards Plan, 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.
• 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.