Job Title: Facilities Engineer Associate
Location: Durham, NC
Type: Direct Hire
Compensation: $47,840.00 - $62,400.00
Work Model: Onsite
Hours: 8:00AM - 5:00PM
Responsibilities
- Perform routine operation, monitoring, and maintenance of facility utilities, including HVAC systems, purified water systems, compressed air systems, boilers, chillers, and electrical equipment.
- Execute and track preventive and corrective maintenance activities on manufacturing and facility equipment to ensure reliable and compliant operations.
- Troubleshoot mechanical, electrical, instrumentation, and facility-related issues and implement effective corrective actions.
- Support equipment qualification, commissioning, validation, calibration, and requalification activities in compliance with cGMP requirements.
- Schedule and coordinate external vendors for calibration, maintenance, and service activities while ensuring timely completion and minimal disruption to operations.
- Collaborate with Production, Quality Assurance, Validation, and Engineering teams to plan maintenance and calibration schedules and support manufacturing operations.
- Maintain accurate maintenance records, work orders, logbooks, asset information, and engineering documentation.
- Create, revise, and maintain Facility & Engineering department Standard Operating Procedures (SOPs), forms, and related documentation.
- Ensure compliance with cGMP, safety regulations, environmental standards, and pharmaceutical industry guidelines.
- Assist in facility improvement projects, equipment upgrades, energy-saving initiatives, and continuous improvement programs.
- Participate in inspections, audits, investigations, and regulatory assessments related to facility, utility, and equipment systems.
- Follow established SOPs and contribute to maintaining a safe, efficient, and compliant work environment.
- Utilize engineering and maintenance software systems such as AutoCAD, PMMS, CMMS, DMS, Nicelon, QAMS, BMS, EMS, and ERP systems to support daily operations, documentation, maintenance planning, and project activities.
- Expected to come on weekends and after hours in case of emergencies at the facility.
Requirements
- Basic knowledge of cGMP regulations, FDA requirements, and pharmaceutical manufacturing practices.
- Understanding of facility utility systems, including HVAC, purified water systems, compressed air systems, boilers, chillers, and electrical distribution systems.
- Familiarity with preventive maintenance, calibration, validation, and equipment qualification activities.
- Experience with maintenance management and documentation systems such as CMMS, PMMS, DMS, QAMS, ERP systems, or similar platforms is preferred.
- Proficiency in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint); experience with AutoCAD is a plus.
- Strong troubleshooting, analytical, and problem-solving skills.
- Excellent organizational, communication, and interpersonal skills with the ability to work effectively in cross-functional teams.
- Ability to manage multiple priorities and coordinate activities with internal stakeholders and external vendors.
- Strong attention to detail and commitment to maintaining accurate documentation and regulatory compliance.
- Knowledge of safety regulations and best practices within manufacturing or pharmaceutical environments.
- Ability to work independently as well as collaboratively in a fast-paced environment.
- Willingness to support off-shift, weekend, or on-call activities as required to support facility operations.
- Bachelor’s Degree in Mechanical Engineering/Facilities or related field of study or equivalent.
- 2–4 years of experience in facility engineering, maintenance, utilities, manufacturing, or a regulated pharmaceutical/biotechnology environment preferred.
System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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