Maintenance Engineer - GMP Manufacturing (North Carolina)

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.

Role – Maintenance Engineer – GMP Manufacturing
Location: North Carolina, USA
*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 Overview

The maintenance engineer supports reliable and compliant operation of manufacturing and utility equipment within a regulated pharmaceutical or biotech environment. The role focuses on preventive and predictive maintenance, troubleshooting, reliability improvement, spare parts and inventory management, and instrument calibration activities, ensuring minimal downtime and full GMP compliance.

Key Responsibilities

• Execute and support preventive and predictive maintenance programs for manufacturing, utility, and facility equipment
• Perform systematic troubleshooting and root cause analysis to resolve equipment and system failures
• Support reliability engineering initiatives to improve equipment uptime and performance
• Manage spare parts, critical spares, and inventory to ensure operational readiness
• Perform and support instrument calibration activities in line with GMP and site procedures
• Ensure maintenance activities are executed in compliance with GMP, EHS, and site SOPs
• Maintain accurate maintenance records, calibration logs, and documentation
• Support change controls, deviations, and CAPA related to maintenance activities
• Coordinate with vendors and contractors for servicing and repairs
• Support audits, inspections, and regulatory requirements as needed

Qualifications & Experience

• Bachelors degree or Diploma in Mechanical, Electrical, Instrumentation, or related Engineering discipline
• 2–6+ years of maintenance experience in a pharmaceutical, biotech, or regulated manufacturing environment
• Hands-on experience with preventive and predictive maintenance practices
• Experience with troubleshooting mechanical, electrical, or instrumentation systems
• Familiarity with GMP requirements, documentation practices, and calibration standards
• Experience using CMMS systems for maintenance and inventory tracking
• Strong problem-solving skills and attention to detail
• Ability to work independently and within cross-functional teams