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 completion of Change Controls, CAPAs, and Deviations
• Lead technical root cause analysis, incident investigations, and troubleshooting for process control issues
• Manage day-to-day operational support, including 24/7 on-call support and system administration
• Prepare and review Standard Operating Procedures (SOP) and cGMP documentation

Requirements

• Bachelor's Degree and 4 years of Engineering experience (or equivalent combination of education and experience)
• Experience with Emerson DeltaV DCS
• Knowledge of GAMPs and GMPs in a highly regulated environment
• Expertise in automation system design and process control engineering
• Experience with troubleshooting and lifecycle management of manufacturing process controls

Preferred Qualifications

• Degree in Electrical, Computer, Chemical, or Biotech Engineering
• Experience with GMP biopharmaceutical production equipment such as bioreactors, chromatography, and TFF
• Familiarity with 21 CFR Part 11, ASTM 2500, S88, and S95 standards
• Experience in Capital Project Lifecycle Management from conceptual design to execution
• Strong leadership, technical writing, and communication skills

Benefits

• Comprehensive health, dental, and vision coverage
• Retirement and Savings Plan with company contributions
• Discretionary annual bonus program
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns

About the Company

Amgen is a leading biotechnology company dedicated to serving patients by discovering, developing, and manufacturing innovative human therapeutics. We leverage advanced biology and manufacturing expertise to address high unmet medical needs and improve health outcomes for millions of people worldwide.