GMP Utilities Engineers North Carolina
Listed on 2026-02-12
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Engineering
Quality Engineering, Process Engineer, Manufacturing Engineer, Operations Engineer
AMTSOL - A leader in Life Science Manufacturing Technology solutions, we are looking for top talent to be part of the dynamic team and drive the growth of the business.
GMP Utilities Engineers (Sr & Jr) - 2 HC. USA (North Carolina). This is a long-term, site-based position supporting GMP manufacturing operations. The role requires candidates to be based in North Carolina or willing to relocate to North Carolina to support on-site operational needs.
Role OverviewThe Clean Utility / Black Utility Engineer is responsible for supporting and managing GMP utility systems to ensure reliable, compliant, and efficient operations in a regulated pharmaceutical or biotech manufacturing environment. The role covers clean utilities (PW, WFI, Clean Steam, Process Gases) and black utilities (HVAC, Chillers, Boilers, Compressed Air, Electrical, UPS, RO, etc.).
Senior EngineerKey Responsibilities
- Lead and oversee daily operations of clean and black utility systems in GMP environments
- Ensure continuous compliance with GMP, EHS, and regulatory requirements
- Monitor, analyze, and optimize system performance and reliability
- Drive energy efficiency and sustainability initiatives across utility systems
- Lead large-scale shutdowns, maintenance planning, and critical system interventions
- Own and manage change controls, deviations, investigations, and CAPA closure
- Review and approve SOPs, risk assessments, and validation-related documentation
- Act as SME during internal and external audits and regulatory inspections
- Manage vendor performance and contractor activities
- Support commissioning, qualification, and validation (IQ/OQ/PQ) of utility systems
- Bachelors degree in Mechanical, Electrical, Chemical, or related Engineering discipline
- 6–10+ years of experience in utility engineering within pharma / biotech / life sciences
- Strong hands-on experience with GMP utility systems (clean & black utilities)
- Proven experience managing change control, deviations, and CAPAs
- Experience leading shutdowns and cross-functional teams
- Strong problem-solving, leadership, and stakeholder management skills
Key Responsibilities
- Support day-to-day operation and monitoring of clean and black utility systems in GMP manufacturing areas
- Perform routine system checks, trend monitoring, and basic troubleshooting
- Assist in maintaining GMP compliance and site documentation
- Support change controls, deviations, and CAPA activities under supervision
- Assist during planned maintenance, shutdowns, and system restarts
- Coordinate with vendors and maintenance teams for routine servicing
- Ensure utilities operate in line with SOPs, safety, and environmental requirements
- Participate in audits and inspections as required
- Bachelors degree in Mechanical, Electrical, Chemical, or related Engineering discipline
- 2–4 years of experience in utilities within a pharma, biotech, or regulated manufacturing environment
- Basic understanding of GMP, EHS, and regulated documentation
- Familiarity with clean utility systems is an advantage
- Good communication and teamwork skills
- Clean Utilities: PW, WFI, Clean Steam, Process Gases
- Black Utilities: HVAC, Chillers, Boilers, Cooling Towers, Compressed Air, Electrical, UPS
- BMS / EMS / SCADA systems
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