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 FAT to ensure control strategy and software code meet requirements
• Drive completion of Change Controls, CAPAs, and Deviations
• 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 documents

Requirements

• Bachelor's Degree and 2 years of Engineering experience, or a Master's Degree
• Experience with Emerson DeltaV DCS systems
• Knowledge of Automation System design
• Experience working with GAMPs and GMPs in a regulated environment
• Strong technical writing and communication skills

Preferred Qualifications

• Degree in Electrical, Computer, Chemical, or Biotech Engineering
• Experience in process control engineering and troubleshooting with GMP biopharmaceutical production equipment
• Experience with programming, installation, and lifecycle management of automation and field instrumentation
• Familiarity with 21 CFR Part 11, ASTM 2500, S88, and S95 standards
• Ability to perform system integration using OPC, Foundation Fieldbus, and Profibus technologies

Benefits

• Comprehensive employee benefits package including medical, dental, and vision coverage
• Retirement and Savings Plan with generous 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 living with serious illnesses. Since 1980, Amgen has pioneered the biotech industry, focusing on therapeutic areas such as Oncology, Inflammation, General Medicine, and Rare Disease to deliver innovative medicines worldwide.