Manufacturing Systems Engineer: Automation - DeltaV Wednesday Shift

Manufacturing Systems Engineer:
Automation – Delta V

The Manufacturing Systems Engineer will work with a group of automation engineers responsible for building and maintaining automation systems that support GMP drug‑substance plant operations.

4 days × 10 hr shift:
Sunday through Wednesday.

• Develop and maintain the process control system on Emerson DeltaV distributed control system (DCS).
• Collaborate with stakeholders and end‑users to understand 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 current Amgen and industry standards.
• Ensure process automation designs meet Amgen specifications, incorporate the latest technology, and satisfy safety requirements.
• Support vendor factory acceptance testing (FAT) to verify control strategy and software code meet Amgen requirements.
• Develop and maintain engineering and maintenance documentation and associated procedures.
• Support commissioning and qualification, including Automation Installation Verification/Automation Check Out (IV/ACO).
• Own and drive completion of change controls, CAPAs, and deviations.
• Support technical root cause analysis, incident investigations, and troubleshooting.
• Support functional area projects for equipment, utilities, and facilities and large capital projects for new technologies.
• Drive continuous improvement of process automation to improve workflows, safety, reliability, efficiency, and sustainability.
• Support day‑to‑day operations and rotational on‑call support.
• Prepare and review SOP and cGMP documents.
• Maintain curiosity and drive technical innovation and cost‑effective solutions.

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

• Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or a related field.
• Direct knowledge of automation system design, process control engineering, and troubleshooting with GMP biopharmaceutical production equipment (media, harvest, bioreactors, solution prep, single‑use mixers, chromatography, TFFL/TFFX, viral filtration/inactivation, 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.
• Proficiency with Emerson DeltaV DCS, OPC, Foundation Fieldbus, and Profibus technologies, and advanced troubleshooting.
• Knowledge of GAMP and GMP, documentation in regulated environments (21 CFR Part 11, ASTM 2500, S88, S95).
• Self‑directed team player capable of cross‑functional collaboration.
• Strong technical writing and communication skills.

Amgen supports professional and personal growth through a comprehensive benefits package, a discretionary annual bonus program, stock‑based incentives, award‑winning time‑off plans, flexible work models, and more.