Senior Manufacturing Automation Engineer – PLC & Industry 4.0

BioSpace; Holly Springs (NC); On-site; USD 110,000 - 160,000; Full time

Job summary

Amgen seeks a Senior Manufacturing Systems Engineer (PLC) to lead automation projects for the FleX Batch facility in North Carolina. You will drive design, build, and qualification of PLC-based systems supporting drug substance production, with 24x7 operations responsibility.

You will work with capital projects, site engineering, and platform leads to ensure robust automation solutions, compliance with 21 CFR Part 11 and GMP, and effective process control across operations.

Qualifications

• High School Diploma/GED with 10+ years of engineering experience.
• Associates Degree with 8+ years of engineering experience.
• Bachelors Degree with 4+ years of engineering experience.
• Masters Degree with 2+ years of engineering experience.
• Doctorate Degree.

Responsibilities

• Lead site design, startup, and operational readiness for manufacturing.
• Develop PLC-based process control automation solutions with process engineering.
• Ensure network connectivity and system-to-system communication for centralized monitoring.
• Assist commissioning and qualification (IV/ACO) activities.
• Collaborate across units for readiness, reviews, deviations, and change control.
• Develop detailed specifications, SOPs, and operating standards impacting multiple units.
• Mentor and develop automation staff and capabilities.
• Provide 24x7 operational support and troubleshooting for systems.
• Lead capital projects and integrate new manufacturing technologies.
• Support new product introductions and technology introductions as needed.

Skills

PLC programming

Automation engineering

Team leadership

Technical writing

Project management

Education

HS Diploma/GED (10+ yrs eng)

Associate degree (8+ yrs eng)

Bachelor's degree (4+ yrs eng)

Master's degree (2+ yrs eng)

Doctorate degree

Tools

Rockwell platforms

Process control systems

Field instrumentation technologies

Job description

Amgen seeks a Senior Manufacturing Systems Engineer (PLC) to lead automation projects for the FleX Batch facility in North Carolina. You will drive design, build, and qualification of PLC-based systems supporting drug substance production, with 24x7 operations responsibility.

You will work with capital projects, site engineering, and platform leads to ensure robust automation solutions, compliance with 21 CFR Part 11 and GMP, and effective process control across operations.