Senior Clean Utilities Engineer - GMP Biopharma

Amgen SA; Holly Springs (NC); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Total Rewards Plan

Stock-based incentives

Paid time off

Flexible work models

Job summary

Amgen NC in North Carolina seeks a senior Utilities Engineer to own Clean and Plant Utility systems, lead design, startup, qualification, and maintenance programs for biotech production facilities. The role requires leadership across design, commissioning, and regulatory interactions to ensure GMP-compliant operations.

You will apply engineering fundamentals to daily operations, drive equipment improvements, and support 24/7 plant uptime with data-driven maintenance and RCA processes, while

Qualifications

• High school diploma / GED with 10 years of Engineering/Maintenance experience, or
• Associate’s degree with 8 years of Engineering/Maintenance experience, or
• Bachelor’s degree with 4 years of Engineering/Maintenance experience, or
• Master’s degree with 2 years of Engineering/Maintenance experience, or
• Doctorate degree

Responsibilities

• Provide system ownership for Clean and Plant Utility systems and equipment supporting operations at the site.
• Provide engineering support for design, construction, startup, commissioning and qualification of new or modified systems.
• Identify, support, and/or lead implementation of engineering-based improvements or upgrades in small to medium scope and complexity to the equipment or facility systems. Lead the development of a business case if required to support the completion of the project.
• Develop equipment maintenance programs, ensure the availability of spare parts, and coordinating maintenance execution as necessary to ensure systems are in proper working order.
• Ensure systems are installed and operating safely and comply with pertinent EH&S practice, rules and regulations.
• Ensure necessary commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors as necessary.
• Apply basic engineering principles and practices in support of daily operation, maintenance, and troubleshooting of plant systems.
• Monitor systems to identify performance risks and implement risk reduction strategies.
• Provide troubleshooting support to reduce production downtime, including RCA and corrective/preventive actions.
• Support new product/technology introductions by performing engineering assessments and supporting runs.
• Advance condition-based and predictive maintenance practices with data analytics where applicable.

Skills

Engineering/Maintenance experience

Education

High school diploma / GED

Associate’s degree in engineering or related field

Bachelor’s degree in Engineering

Master’s degree

Doctorate degree

Job description

Amgen NC in North Carolina seeks a senior Utilities Engineer to own Clean and Plant Utility systems, lead design, startup, qualification, and maintenance programs for biotech production facilities. The role requires leadership across design, commissioning, and regulatory interactions to ensure GMP-compliant operations.

You will apply engineering fundamentals to daily operations, drive equipment improvements, and support 24/7 plant uptime with data-driven maintenance and RCA processes, while