Facilities Maintenance Engineer

POSITION TITLE:

Facilities Maintenance Engineer

REPORTS INTO:
Facilities Manager

The Facilities Maintenance Engineer will support the successful build out, commissioning, maintenance, and continuous operation of a state‑of‑the‑art medical device manufacturing facility producing media and solutions for fertility centers. This role will focus on maintaining facility systems, utilities, manufacturing support equipment, and cleanroom environments to ensure reliable, compliant, and efficient operations.

Working closely with the Facilities Manager, the Facilities Maintenance Engineer will support equipment installation and qualification activities, troubleshoot facility and utility issues, coordinate maintenance activities, and help drive continuous improvement initiatives across the site. This position will play a key role in sustaining GMP compliant operations and supporting future site growth.

• Support daily operation, monitoring, troubleshooting, and repair of facility systems, utilities, and manufacturing support equipment.
• Assist with facility build out activities, equipment installation, commissioning, and qualification efforts, including IQ/OQ/PQ support.
• Execute and continuously improve preventive maintenance programs for facility systems, utilities, clean rooms, and production support equipment.
• Maintain accurate maintenance records, calibration records, equipment logs, and supporting documentation in accordance with GMP and quality system requirements.
• Support cleanroom operations (ISO 5-8), including monitoring, troubleshooting environmental excursions, and coordinating maintenance activities to minimize production disruption.
• Coordinate and oversee external contractors and service providers performing maintenance, calibration, and repair activities.
• Respond to facility and equipment issues in a timely manner to minimize downtime and maintain operational continuity.
• Assist in investigations, root cause analysis, corrective actions, and continuous improvement initiatives related to facilities and equipment.
• Ensure maintenance activities are performed in compliance with safety requirements, GMP expectations, and applicable regulatory standards.
• Support facility related audits and inspections by providing documentation, records, and technical support.
• Collaborate cross functionally with Manufacturing, Quality, and Engineering teams to support site objectives.
• Assist in spare parts management, inventory tracking, and vendor coordination for maintenance related activities.
• Support implementation and optimization of computerized maintenance management systems (CMMS), where applicable.
• Participate in after hours or early morning support activities as required to support site operations.
• Perform all other ad‑hoc duties as required and / or requested by Manager.
• Bachelor’s degree in Engineering, Facilities Engineering, Mechanical Engineering, Electrical Engineering, or related technical discipline preferred; equivalent technical experience may be considered in lieu of a degree.
• At least 3 years of facilities, maintenance, or equipment engineering experience within medical device, pharmaceutical, biotechnology, or other regulated manufacturing industries.
• Experience supporting GMP manufacturing environments and regulated facility operations.
• Familiarity with cleanroom operations (ISO 5-8), utility systems, and equipment maintenance practices.

• Working knowledge of facility utility systems including HVAC, compressed gases, purified water systems, electrical systems, and environmental controls.
• Understanding of equipment qualification, calibration, preventive maintenance, and documentation practices within regulated environments.
• Strong troubleshooting and root cause analysis skills with the ability to resolve technical issues efficiently.
• Ability to read and interpret engineering drawings, P&IDs, equipment manuals, and technical documentation.
• Strong organizational skills with attention to detail and documentation accuracy.
• Effective communication and interpersonal skills with the ability to work collaboratively across departments and with external contractors.
• Ability to prioritize multiple tasks in a fast‑paced manufacturing environment.
• Commitment to safety, quality, compliance, and continuous improvement.
• Willingness and ability to work early morning hours and support occasional off shift activities.