Senior Clean Utilities Engineer – GMP Biopharma Operations

Amgen Inc.; Holly Springs (NC); On-site; USD 115,000 - 156,000; Full time

Job summary

Amgen Inc. in North Carolina seeks a Senior Engineer for Clean Utilities to own and optimize plant utility systems in a GMP biopharmaceutical setting. You will design, commission, qualify and troubleshoot equipment such as water systems, steam, and air generation to support drug substance production.

The role requires strong engineering knowledge, data analytics, RCA and SPC skills, and the ability to lead cross-functional teams in a highly regulated environment. Travel may be required.

Qualifications

• High school diploma / GED and 10 years of Engineering/Maintenance experience OR
• Associate’s degree and 8 years of Engineering/Maintenance experience OR
• Bachelor’s degree and 4 years of Engineering/Maintenance experience OR
• Master’s degree and 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.
• Develop equipment maintenance programs, ensure availability of spare parts, and coordinate maintenance execution as necessary to ensure systems are in proper working order.
• Ensure systems are installed and operating safety and comply with pertinent environmental health/safety 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.
• Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.
• Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
• Advance the use of condition based and predictive maintenance practices by incorporating advanced data analytics where applicable.
• Own investigations of abnormal conditions through Deviation and business processes.

Skills

Data analytics

Root Cause Analysis

Statistical Process Control

Six Sigma

Leadership

Communication

Education

Bachelor’s in Chemical/Mechanical/Electrical Eng

Job description

Amgen Inc. in North Carolina seeks a Senior Engineer for Clean Utilities to own and optimize plant utility systems in a GMP biopharmaceutical setting. You will design, commission, qualify and troubleshoot equipment such as water systems, steam, and air generation to support drug substance production.

The role requires strong engineering knowledge, data analytics, RCA and SPC skills, and the ability to lead cross-functional teams in a highly regulated environment. Travel may be required.