Clean Utilities Engineer
On-siteHolly Springs, North Carolina, United States
Job Summary
Provide daily engineering support at the Amgen North Carolina site, including system ownership for utility equipment and troubleshooting to reduce production downtime. Lead design, construction, startup, and qualification of new systems while developing maintenance programs and managing spare parts availability. Implement engineering-based improvements, conduct root cause analysis for abnormal conditions, and support new product introductions through equipment modifications and engineering runs. Ensure all operations comply with GMP requirements and environmental health/safety regulations, providing 24x7 on-call support on a rotational basis. Evaluate suppliers and assess technologies for cost savings and throughput improvements.
Required Qualifications
- High school diploma / GED and 8 years of Engineering/Maintenance experience
- Associate's degree and 6 years of Engineering/Maintenance experience
- Bachelor's degree and 2 years of Engineering/Maintenance experience
- Master's degree
- Bachelor's degree in chemical or mechanical engineering
- 2+ years of relevant work experience
- 2+ years' experience in Biopharmaceutical operations/manufacturing environment
- Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility utility equipment/systems such as Pharmaceutical Water, Clean Steam, Clean Air generation and distribution, and CIP
- Experience with other Plant Utility equipment needed to support these processes such as Chilled Water chillers, cooling towers, steam boilers, air compressors, etc.
- Experience with equipment and facility control systems operation, logic, and troubleshooting
- Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.)
- familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
- Strong leadership, technical writing, communication/presentation skills and the ability to work with minimum direction
- Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team-based environment
- Ability to apply analytical skills to evaluate and interpret sophisticated problems using multiple sources of information
- Ability to function within cross-functional teams and embrace a team-based environment
- Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects
- Understanding of the execution process of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation
- Understanding safety requirements working in a GMP Biopharmaceutical Production facility
- Independent, ambitious, organized, able to multi-task in project environments, and skilled in communication, facilitation, and teamwork
- Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage
- Support may be required outside of normal working hours including nights, weekends, and holidays
Desired Qualifications
- Ability to work in a small group of engineers and/or technicians on an ongoing or project basis
- Ability to apply engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects
- Understanding of the execution process of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation
- Understanding safety requirements working in a GMP Biopharmaceutical Production facility
- Independent, ambitious, organized, able to multi-task in project environments, and skilled in communication, facilitation, and teamwork
- Great teammates prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making
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