Clean Utilities Engineer
Amgen
August 21, 2026
On-site
Holly Springs, NC
Operations
CLEAN UTILITIES ENGINEER
What You Will Do:
- Provide daily engineering support at the Amgen North Carolina site; report to the Senior Manager of the Process Engineering group.
- Provide system ownership for utility systems/equipment supporting operations.
- Support design, construction, startup, commissioning, and qualification of new/modified systems.
- Lead engineering improvements/upgrades (small to medium scope/complexity); develop business case if required.
- Develop maintenance programs, ensure spare parts availability, and coordinate maintenance execution.
- Ensure safe installation/operation and compliance with environmental health/safety rules.
- Ensure commissioning/qualification aligns with GMP requirements; interact with regulatory inspectors as needed.
- Perform daily operation/maintenance/troubleshooting; apply engineering principles.
- Monitor performance risks; implement risk reduction strategies.
- Troubleshoot to reduce downtime; lead/support root cause analysis and CAPA.
- Support new product/technology introductions (assessments, equipment modifications, engineering runs).
- Advance condition-based/predictive maintenance using advanced data analytics.
- Own investigations of abnormal conditions via deviation/business processes.
- Develop/coordinate/analyze/present results for operational issues and engineering projects.
- Provide technical support to manufacturing (process control/equipment) for commercial and clinical needs.
- Coordinate with manufacturing, process engineering/development, utility operations, maintenance, QA, validation.
- Communicate issues and propose solutions; work in small engineer/technician teams.
- Provide 24x7 rotational on-call support (nights/weekends/holidays).
- Lead/work on design/development/selection of new systems, instruments, calibration capabilities, consumables.
- Evaluate suppliers and assess new technologies for cost/throughput/other benefits.
What We Expect Of You
Basic Qualifications:
- High school diploma/GED + 8 years engineering/maintenance experience OR
- Associate’s degree + 6 years OR
- Bachelor’s degree + 2 years OR
- Master’s degree
Preferred Qualifications:
- Bachelor’s degree in chemical or mechanical engineering.
- 2+ years relevant experience, including 2+ years biopharmaceutical operations/manufacturing.
- GMP utility equipment/systems knowledge (pharmaceutical water, clean steam/air, CIP; chilled water chillers, cooling towers, steam boilers, air compressors).
- Experience with equipment/facility control systems operation, logic, and troubleshooting.
- Regulated environment experience (cGMP, OSHA, EPA) and GMP systems knowledge (change control, non-conformances, CAPA, qualification/validation).
- Leadership, technical writing, communication/presentation; can work with minimum direction.
- Analytical/problem-solving skills; strong interpersonal/facilitation; cross-functional collaboration.
- Experience with system modifications, new process introductions, and capital projects.
- Understanding of capital project execution in GMP facilities (procurement, construction, startup, validation) and safety requirements.
- Flexibility for 24/7 operations and occasional after-hours coverage.
Benefits (explicitly stated):
- Comprehensive benefits package including retirement/savings plan (company contributions), medical/dental/vision, life/disability insurance, flexible spending accounts; discretionary annual bonus; stock-based long-term incentives; award-winning time-off; flexible work models where possible.
Application Instructions:
- Apply at careers.amgen.com; no application deadline—applications accepted until sufficient candidates are received or a candidate is selected.
What You Will Do:
- Provide daily engineering support at the Amgen North Carolina site; report to the Senior Manager of the Process Engineering group.
- Provide system ownership for utility systems/equipment supporting operations.
- Support design, construction, startup, commissioning, and qualification of new/modified systems.
- Lead engineering improvements/upgrades (small to medium scope/complexity); develop business case if required.
- Develop maintenance programs, ensure spare parts availability, and coordinate maintenance execution.
- Ensure safe installation/operation and compliance with environmental health/safety rules.
- Ensure commissioning/qualification aligns with GMP requirements; interact with regulatory inspectors as needed.
- Perform daily operation/maintenance/troubleshooting; apply engineering principles.
- Monitor performance risks; implement risk reduction strategies.
- Troubleshoot to reduce downtime; lead/support root cause analysis and CAPA.
- Support new product/technology introductions (assessments, equipment modifications, engineering runs).
- Advance condition-based/predictive maintenance using advanced data analytics.
- Own investigations of abnormal conditions via deviation/business processes.
- Develop/coordinate/analyze/present results for operational issues and engineering projects.
- Provide technical support to manufacturing (process control/equipment) for commercial and clinical needs.
- Coordinate with manufacturing, process engineering/development, utility operations, maintenance, QA, validation.
- Communicate issues and propose solutions; work in small engineer/technician teams.
- Provide 24x7 rotational on-call support (nights/weekends/holidays).
- Lead/work on design/development/selection of new systems, instruments, calibration capabilities, consumables.
- Evaluate suppliers and assess new technologies for cost/throughput/other benefits.
What We Expect Of You
Basic Qualifications:
- High school diploma/GED + 8 years engineering/maintenance experience OR
- Associate’s degree + 6 years OR
- Bachelor’s degree + 2 years OR
- Master’s degree
Preferred Qualifications:
- Bachelor’s degree in chemical or mechanical engineering.
- 2+ years relevant experience, including 2+ years biopharmaceutical operations/manufacturing.
- GMP utility equipment/systems knowledge (pharmaceutical water, clean steam/air, CIP; chilled water chillers, cooling towers, steam boilers, air compressors).
- Experience with equipment/facility control systems operation, logic, and troubleshooting.
- Regulated environment experience (cGMP, OSHA, EPA) and GMP systems knowledge (change control, non-conformances, CAPA, qualification/validation).
- Leadership, technical writing, communication/presentation; can work with minimum direction.
- Analytical/problem-solving skills; strong interpersonal/facilitation; cross-functional collaboration.
- Experience with system modifications, new process introductions, and capital projects.
- Understanding of capital project execution in GMP facilities (procurement, construction, startup, validation) and safety requirements.
- Flexibility for 24/7 operations and occasional after-hours coverage.
Benefits (explicitly stated):
- Comprehensive benefits package including retirement/savings plan (company contributions), medical/dental/vision, life/disability insurance, flexible spending accounts; discretionary annual bonus; stock-based long-term incentives; award-winning time-off; flexible work models where possible.
Application Instructions:
- Apply at careers.amgen.com; no application deadline—applications accepted until sufficient candidates are received or a candidate is selected.