Onsite Facilities Engineer - GMP Maintenance & Ops

System One; Durham (NC); On-site; USD 48,000 - 62,000; Full time

Benefits offered by this job

Health, dental, vision benefits

401(k) plan

Life insurance

Spending accounts

Voluntary plans

Job summary

System One is seeking a Facilities Engineer Associate in Durham, NC for a direct-hire, onsite role with standard hours (8:00 AM – 5:00 PM). The position involves maintaining and troubleshooting facility utilities and equipment within a regulated pharmaceutical/biotech environment.

The role requires a Bachelor’s degree in Mechanical Engineering/Facilities or related field and 2–4 years of relevant experience.

Qualifications

• Bachelor's degree in Mechanical Engineering/Facilities or related field.
• 2–4 years of experience in facility engineering, maintenance, utilities, or a regulated pharmaceutical/biotechnology environment preferred.
• Experience with maintenance management and documentation systems such as CMMS, PMMS, DMS, QAMS, ERP systems, or similar platforms is preferred.
• Proficiency in Microsoft Office; AutoCAD experience is a plus.

Responsibilities

• Perform routine operation, monitoring, and maintenance of facility utilities, including HVAC, purified water, compressed air, boilers, chillers, and electrical equipment.
• Execute preventive and corrective maintenance activities to ensure reliable and compliant operations.
• Troubleshoot mechanical, electrical, instrumentation, and facility-related issues and implement corrective actions.
• Support equipment qualification, commissioning, validation, calibration, and requalification activities in cGMP guidelines.
• Coordinate external vendors for calibration, maintenance, and service with minimal disruption to operations.
• Collaborate with Production, Quality Assurance, Validation, and Engineering teams to plan maintenance schedules.
• Maintain maintenance records, work orders, logbooks, asset information, and engineering documentation.
• Create and maintain SOPs, forms, and related Facility & Engineering documentation.

Skills

Troubleshooting

Analytical thinking

Problem-solving

Organizational skills

Communication skills

Education

Bachelor's Degree in Mechanical Engineering/Facilities or related field

Tools

AutoCAD

CMMS

PMMS

DMS

QAMS

ERP systems

Job description

System One is seeking a Facilities Engineer Associate in Durham, NC for a direct-hire, onsite role with standard hours (8:00 AM – 5:00 PM). The position involves maintaining and troubleshooting facility utilities and equipment within a regulated pharmaceutical/biotech environment.

The role requires a Bachelor’s degree in Mechanical Engineering/Facilities or related field and 2–4 years of relevant experience.