Pharma Facilities Engineer - GMP Utilities & Maintenance

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

Benefits offered by this job

Medical, dental, vision coverage

Life insurance

401(k) plan

Job summary

System One is seeking a Facilities Engineer Associate in Durham, NC, for a direct-hire role. The candidate will maintain facility utilities, support calibration and validation activities, and coordinate with cross-functional teams to ensure compliant operations.

The job requires a Bachelor’s in Mechanical Engineering/Facilities and 2–4 years in a regulated environment, with weekend/on-call availability for emergencies. Onsite work with standard daytime hours.

Qualifications

• Knowledge of cGMP regulations and FDA requirements.
• Experience with facility utility systems (HVAC, water, boilers, chillers, electrical).
• Experience with maintenance planning and documentation systems (CMMS/PMMS/DMS/ERP).
• Proficient in documentation and SOPs; attention to regulatory compliance.
• Strong problem-solving, organizational, and cross-functional collaboration skills.

Responsibilities

• Operate, monitor, and maintain facility utilities and equipment.
• Plan and execute preventive and corrective maintenance activities.
• Troubleshoot mechanical, electrical, and instrumentation issues.
• Support qualification, commissioning, and validation activities per cGMP.
• Coordinate external vendors for calibration and service work.
• Collaborate with Production, QA, Validation, and Engineering teams.
• Maintain accurate records, SOPs, and engineering documentation.
• Utilize AutoCAD and maintenance software to support daily operations.

Skills

Preventive maintenance

Troubleshooting

Calibration

Documentation

Cross-functional teamwork

Microsoft Office (Word/Excel/Outlook)

AutoCAD

CMMS/PMMS/DMS experience

Regulatory compliance

Education

Bachelors in Mechanical Engineering/Facilities

Tools

AutoCAD

PMMS

CMMS

DMS

QAMS

ERP systems

BMS/EMS

Job description

System One is seeking a Facilities Engineer Associate in Durham, NC, for a direct-hire role. The candidate will maintain facility utilities, support calibration and validation activities, and coordinate with cross-functional teams to ensure compliant operations.

The job requires a Bachelor’s in Mechanical Engineering/Facilities and 2–4 years in a regulated environment, with weekend/on-call availability for emergencies. Onsite work with standard daytime hours.