Senior Manufacturing Systems Engineer (PLC Systems)

Location: Holly Springs, North Carolina, United States; onsite role with 24 x 7 onsite/on-call operational support. Up to 10% domestic and international travel is required.

Company

Amgen develops, manufactures, and delivers biotech medicines across oncology, inflammation, general medicine, and rare disease therapeutic areas.

What you will do

• Lead technical projects and automation solutions for PLC-based processes and utility skid equipment.
• Partner with capital project and process engineering teams to design, build, commission, and qualify equipment and systems for drug substance production.
• Ensure PLC systems have appropriate network connectivity, system-to-system communication, centralized monitoring, and alarming.
• Provide operational support, troubleshooting, preventive and corrective maintenance, system administration, and spare-parts management.
• Lead root cause analyses, incident investigations, new product or technology introductions, and automation configuration changes.
• Develop specifications, SOPs, operating standards, cGMP documentation, and mentor automation engineering staff.

Requirements

• Engineering experience aligned with education: 10 years with a high school diploma/GED, 8 years with an associate degree, 4 years with a bachelor's degree, 2 years with a master's degree, or a doctorate degree.
• Experience with process and utility skid equipment, OEM automation software, field instrumentation, and Rockwell platforms.
• Experience programming, designing, installing, and managing the lifecycle of PLC, process-control, automation, and field-instrumentation systems.
• Knowledge of biopharmaceutical manufacturing automation and standards including 21 CFR Part 11, ASTM 2500, S88, S95, GAMP, GDP, and GMP.
• Experience with capital project lifecycle management, including conceptual design, detailed design, implementation, and validation.
• Strong leadership, technical writing, communication, and presentation skills, with the ability to mentor engineering staff.

Culture & Benefits

• Collaborative, innovative, science-based work environment.
• Opportunity to support a new drug substance facility featuring disposable technologies, stainless steel equipment, and industry 4.0 capabilities.
• Work connected to sustainability initiatives intended to reduce carbon emissions and waste.
• Competitive salary and comprehensive total rewards aligned with local industry standards.
• Inclusive environment focused on professional growth, well-being, and serving patients.