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
• 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
• Experience with Emerson DeltaV DCS
• Experience in GMP biopharmaceutical production environments
• Strong background in automation system design and process control engineering
• Proficiency in technical writing and project management

Preferred Qualifications

• Degree in Electrical, Computer, Chemical, or Biotech Engineering
• Experience with automation for bioreactors, chromatography, TFF, and viral filtration
• Knowledge of GAMPs, GMPs, and 21 CFR Part 11 regulations
• Experience in Capital Project Lifecycle Management and New Product Introduction (NPI)
• Familiarity with network segregation, virtual infrastructure, and integration technologies like OPC or Profibus

Benefits

• Comprehensive health, dental, and vision insurance
• 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 discovering, developing, and manufacturing innovative human therapeutics. We focus on areas of high unmet medical need to improve health outcomes and transform the lives of millions of patients worldwide.