Manufacturing Systems Engineer: Automation - DeltaV Wednesday Shift

Manufacturing Systems Engineer:
Automation – Delta V

Join Amgen’s mission of serving patients. Amgen, founded in 1980, is a global biotechnology pioneer committed to discovering, developing, manufacturing, and delivering innovative therapeutic solutions that improve patient lives. As part of the newest drug substance manufacturing plant, you will help transform the lives of patients while advancing your career.

In this vital role as part 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.

Schedule: 4 days × 10‑hour shift:
Sunday through Wednesday.

• Develop and maintain the process control system on the Emerson DeltaV distributed control system (DCS).
• Collaborate with key stakeholders and end‑users to understand and synthesize process requirements, and develop solutions using Amgen’s standard automation platform.
• Provide clear documentation for delivered solutions and processes.
• Support QA partners in performing computerized systems validation in a GxP environment.
• Perform Data Integrity Assessments (DIA) in accordance with current Amgen and industry standards.
• Ensure process automation systems align with Amgen specifications, incorporate the latest technology, and meet safety requirements.
• Support vendor FAT to ensure that 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.
• Own and drive to completion Change Controls, CAPAs, and Deviations.
• Support technical root cause analysis, incident investigations, and troubleshooting.
• Support functional area projects focused on process equipment, utilities, and facilities improvements, and large capital projects to integrate new drug substance manufacturing technologies.
• Drive continuous improvement for process automation systems to enhance operational workflows, safety, reliability, efficiency, and sustainability.
• Support day‑to‑day operations, including rotational on‑call support.
• Prepare and review Standard Operating Procedures (SOP) and cGMP documents.

Be constantly curious and feed your passion and interests in groundbreaking technology. Use your time to look for new and innovative ways to do business differently, better, and more cost‑effectively.

Basic Qualifications

• High School Diploma / GED with 8 years of engineering experience OR
• Associate’s Degree with 6 years of engineering experience OR
• Bachelor’s Degree with 2 years of engineering experience OR
• Master’s Degree (preferred)

Preferred qualifications

• Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field.
• Direct knowledge of automation system design, process control engineering, and troubleshooting within GMP biopharmaceutical production facilities (e.g., media, harvest, bioreactors, solution prep, single‑use mixing vessels, chromatography, TFFL/TFFX, viral filtration, viral inactivation, UF/DF, depth filtration, drug substance fill, CIP/SIP, clean utilities) and integration of OEM automation software.
• Experience programming, installing, and managing automation and field instrumentation technologies.
• Experience in manufacturing process controls and automation lifecycle management.
• Experience with Emerson DeltaV DCS, advanced troubleshooting, and system integration using OPC, Foundation Fieldbus, and Profibus technologies.
• Ability to interpret and apply GAMPs and GMPs, and familiarity with regulatory documentation requirements such as 21 CFR Part 11, ASTM 2500, S88, and S95.
• Self‑directed team player able to work cross‑functionally.
• Strong technical writing and communication skills.

• 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.

Salary Range: $ – $ USD