Advanced Manufacturing Tech Solutions · 15 hours ago
GMP Utilities Engineers - USA (North Carolina)
North Carolina, United States
Full-time
Onsite
Entry, Mid, Senior Level
2+ years expAdvanced Manufacturing Tech Solutions is a leader in Life Science Manufacturing Technology solutions, seeking top talent to join their dynamic team. The GMP Utilities Engineer role involves supporting and managing utility systems in a regulated pharmaceutical environment, ensuring compliance and operational efficiency.
Pharmaceuticals
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
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
Qualification
Required
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
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
Preferred
Clean Utilities: PW, WFI, Clean Steam, Process Gases
Black Utilities: HVAC, Chillers, Boilers, Cooling Towers, Compressed Air, Electrical, UPS
BMS / EMS / SCADA systems
Company
Advanced Manufacturing Tech Solutions
We are Delivering Innovation through Technology for Life Science Manufacturing.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase