Clean Utilities Sr Engineer
Amgen
July 01, 2026
On-site
Holly Springs, NC
Operations
CLEAN UTILITIES SR. ENGINEER
Responsibilities:
- Provide system ownership for Clean and Plant Utility systems and equipment supporting site operations.
- Support design, construction, startup, commissioning, and qualification of new or modified systems.
- Identify and lead small to medium scope engineering improvements/upgrades; develop business cases if needed.
- Develop maintenance programs; ensure spare parts availability; coordinate maintenance execution.
- Ensure systems are installed and operating safely and comply with environmental health/safety rules and regulations.
- Complete commissioning/qualification aligned with GMP requirements; interact with regulatory inspectors as needed.
- Apply engineering principles for daily operation, maintenance, and troubleshooting.
- Monitor system performance, identify risks, and implement risk reduction strategies.
- Provide troubleshooting support to reduce production downtime, including root cause analysis and CAPA.
- Support new product/technology introductions via engineering assessments and equipment modifications.
- Advance condition-based/predictive maintenance using data analytics.
- Own investigations of abnormal conditions via deviation and business processes.
Basic Qualifications:
- High school diploma/GED + 10 years Engineering/Maintenance OR Associate’s + 8 years OR Bachelor’s + 4 years OR Master’s + 2 years OR Doctorate.
Preferred Qualifications:
- BS in Chemical/Mechanical/Electrical Engineering.
- 4+ years relevant experience with 2+ years in biopharmaceutical operations/manufacturing.
- GMP utility equipment knowledge (Pharmaceutical Water, Clean Steam, Clean Air; chilled water chillers, cooling towers, steam boilers, air compressors, etc.).
- Control systems troubleshooting; data-driven problem solving (analytics/RCA/SPC/Six Sigma/predictive maintenance).
- Regulated environment experience (cGMP, OSHA, EPA) and GMP quality system familiarity.
- Engineering for system modifications and capital projects; GMP execution knowledge (procurement, construction, startup, validation); GMP safety understanding.
- Strong leadership, technical writing, communication/presentation; flexibility for 24/7 coverage; domestic/international travel.
Benefits:
- Retirement and Savings Plan (company contributions); medical/dental/vision; life/disability; flexible spending accounts; discretionary annual bonus; stock-based long-term incentives; time-off plans; flexible work models where possible.
Application Instructions:
- Apply at careers.amgen.com. No application deadline; applications continue until a sufficient number are received or a candidate is selected.
Responsibilities:
- Provide system ownership for Clean and Plant Utility systems and equipment supporting site operations.
- Support design, construction, startup, commissioning, and qualification of new or modified systems.
- Identify and lead small to medium scope engineering improvements/upgrades; develop business cases if needed.
- Develop maintenance programs; ensure spare parts availability; coordinate maintenance execution.
- Ensure systems are installed and operating safely and comply with environmental health/safety rules and regulations.
- Complete commissioning/qualification aligned with GMP requirements; interact with regulatory inspectors as needed.
- Apply engineering principles for daily operation, maintenance, and troubleshooting.
- Monitor system performance, identify risks, and implement risk reduction strategies.
- Provide troubleshooting support to reduce production downtime, including root cause analysis and CAPA.
- Support new product/technology introductions via engineering assessments and equipment modifications.
- Advance condition-based/predictive maintenance using data analytics.
- Own investigations of abnormal conditions via deviation and business processes.
Basic Qualifications:
- High school diploma/GED + 10 years Engineering/Maintenance OR Associate’s + 8 years OR Bachelor’s + 4 years OR Master’s + 2 years OR Doctorate.
Preferred Qualifications:
- BS in Chemical/Mechanical/Electrical Engineering.
- 4+ years relevant experience with 2+ years in biopharmaceutical operations/manufacturing.
- GMP utility equipment knowledge (Pharmaceutical Water, Clean Steam, Clean Air; chilled water chillers, cooling towers, steam boilers, air compressors, etc.).
- Control systems troubleshooting; data-driven problem solving (analytics/RCA/SPC/Six Sigma/predictive maintenance).
- Regulated environment experience (cGMP, OSHA, EPA) and GMP quality system familiarity.
- Engineering for system modifications and capital projects; GMP execution knowledge (procurement, construction, startup, validation); GMP safety understanding.
- Strong leadership, technical writing, communication/presentation; flexibility for 24/7 coverage; domestic/international travel.
Benefits:
- Retirement and Savings Plan (company contributions); medical/dental/vision; life/disability; flexible spending accounts; discretionary annual bonus; stock-based long-term incentives; time-off plans; flexible work models where possible.
Application Instructions:
- Apply at careers.amgen.com. No application deadline; applications continue until a sufficient number are received or a candidate is selected.