Manufacturing Systems Engineer: Automation

Responsibilities

• Develop and maintain process control systems on the Emerson DeltaV distributed control system (DCS)
• Collaborate with stakeholders to synthesize process requirements and develop solutions using standard automation platforms
• Support QA partners in performing computerized systems validation within a GxP environment
• Perform Data Integrity Assessments (DIA) in accordance with industry standards
• Support vendor Factory Acceptance Testing (FAT) to ensure software code meets requirements
• Drive Change Controls, CAPAs, and Deviations to completion
• Support technical root cause analysis, incident investigations, and troubleshooting
• Drive continuous improvement for process automation systems to improve safety, reliability, and efficiency
• Prepare and review Standard Operating Procedures (SOP) and cGMP documentation

Requirements

• Bachelor's degree and 2 years of engineering experience, or a Master's degree
• Experience with Emerson DeltaV DCS systems
• Knowledge of GMP biopharmaceutical production and GxP environments
• Strong technical writing and communication skills
• Ability to work cross-functionally in a fast-paced environment

Preferred Qualifications

• Degree in Electrical, Computer, Chemical, or Biotech Engineering
• Direct knowledge of automation system design and process control engineering
• Experience with biopharmaceutical equipment such as bioreactors, chromatography, and TFF
• Experience with programming, installation, and lifecycle management of automation technologies
• Familiarity with GAMPs, 21 CFR Part 11, ASTM 2500, S88, and S95 standards

About the Company

Amgen is a leading biotechnology company dedicated to serving patients living with serious illnesses. Since 1980, Amgen has pioneered advancements in oncology, inflammation, general medicine, and rare diseases. The company focuses on discovering, manufacturing, and delivering innovative human therapeutics to improve health outcomes worldwide.