Senior Manufacturing Systems Engineer - Automation PLC

About the role

Amgen is hiring a Senior Manufacturing Systems Engineer for its new FleX batch facility, a drug substance manufacturing plant combining disposable technologies with stainless steel equipment and Industry 4.0 capabilities. You will lead automation engineers in building and maintaining automation systems that support GMP drug substance plant operations, working with the capital project team on utility and standalone systems.

Key responsibilities

• Develop and maintain automation solutions using PLCs such as Allen Bradley and Siemens, integrated with the Emerson DeltaV system
• Maintain SCADA, Trailblazer reporting, equipment PLCs and interface hardware
• Lead and support standalone system implementation and start-up, and guide control panel and HMI layout and design
• Translate process requirements from SMEs into digital automated solutions and build business processes aligned with project timelines
• Provide documentation, support computerized systems validation in a GxP environment, and maintain Data Integrity Assessments
• Lead continuous improvement, root cause analysis, incident investigations, troubleshooting, NPI automation assessments and qualification runs
• Provide 24x7 onsite/on-call operational support, preventative and corrective maintenance, and spare parts management
• Develop engineering policies and procedures and mentor engineering staff

Required profile

• Basic: high school diploma/GED and 10 years of engineering experience, or associate's degree and 8 years, or bachelor's degree and 4 years, or master's degree and 2 years
• Preferred: degree in electrical, computer, chemical or biotech engineering
• Self-directed team player ready to mentor engineers, with strong leadership, technical writing and presentation skills

Required skills

• PLC design, controls engineering and troubleshooting in GMP biopharmaceutical facilities
• Programming, design, installation and lifecycle management of standalone controls, PLCs and field devices
• Rockwell automation hardware and systems; OPC, Foundation Fieldbus, Profibus and DeviceNet
• GAMPs and GMPs, 21 CFR Part 11, ASTM 2500, S88 and S95
• Capital project lifecycle management and process control strategy development

Amgen offers a competitive total rewards package in addition to base salary.