Manufacturing Systems Engineer: Automation - Delta V

Manufacturing Systems Engineer:
Automation - Delta V

As a Manufacturing Systems Engineer, you will work with a group of automation engineers who are responsible for building and maintaining various automation systems and platforms that support the GMP Drug Substance Plant Operations. In this vital role as a member 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.

• Develop and maintain the process control system on Emerson DeltaV distributed 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 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.
• Support process automation systems to 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 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 to completion 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 to integrate new drug substance manufacturing technologies into the facility.
• 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 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‑effective.

• 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 within GMP biopharmaceutical production facility equipment/systems automation (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 integrating various OEM automation software).
• Experience in programming, installation, and lifecycle management of automation and field instrumentation technologies.
• Experience with Emerson DeltaV DCS system and ability to perform advanced troubleshooting, and system integration using OPC, Foundation Fieldbus, and Profibus technologies.
• Ability to interpret and apply GAMPs and GMPs, and familiarity with documentation in a highly regulated environment with 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, and 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.