Senior Manufacturing Systems Engineer: Automation

Responsibilities

• Provide automation technical leadership to build and maintain automation systems supporting GMP Drug Substance Plant Operations
• Develop and maintain process control systems on the Emerson DeltaV distributed control system (DCS)
• Collaborate with process subject matter experts to transform requirements into digital automated solutions
• Support commissioning and qualification efforts, including Automation Installation Verification and Check Out
• Drive Change Controls, CAPAs, and Deviations to completion
• Lead technical root cause analysis, incident investigations, and troubleshooting for process control issues
• Support new product and technology introductions through automation engineering assessments and system configuration
• Provide 24/7 onsite/on-call operational support and troubleshooting for plant and manufacturing operations

Requirements

• Bachelor's degree and 4 years of engineering experience, or Master's degree and 2 years of engineering experience
• Experience with Emerson DeltaV DCS
• Knowledge of GMP biopharmaceutical production and GxP environments
• Experience in automation system design and process control engineering

Preferred Qualifications

• Degree in Electrical, Computer, Chemical, or Biotech Engineering
• Direct experience with biopharmaceutical equipment such as bioreactors, chromatography, and single-use mixing vessels
• Extensive background in programming, design, and lifecycle management of manufacturing process controls
• Familiarity with GAMPs, GMPs, and regulatory requirements like 21 CFR Part 11
• Experience in Capital Project Lifecycle Management from conceptual design through execution

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 to deliver innovative medicines worldwide.