Purpose of Job
This role has been created to support the establishment and operation of MeiraGTx's internal manufacturing facility for Advanced Therapy Medicinal Products (ATMPs), including gene therapy viral vectors for Phase 3 and commercial supply.
The Facilities Maintenance Engineer will support the Engineering Manager in the day-to-day operation, reliability, and continuous improvement of site facilities, cleanroom utilities, and manufacturing equipment. The role operates within a highly regulated GMP environment and provides broad exposure to cleanroom and utility systems, capital projects, and operational support activities.
This is a hands-on role requiring flexibility, strong technical capability, and a proactive approach to asset care, compliance, and continuous improvement as the facility continues to develop towards commercial operation.
Key Responsibilities
Facilities, Utilities & Asset Care
* Deliver day-to-day asset care activities across facilities, utilities, and manufacturing equipment.
* Ensure the availability, reliability, and performance of cleanroom utilities and building services to meet operational requirements.
* Develop, execute, and maintain preventative maintenance (PPM), reactive, and unplanned maintenance activities using the Maximo CMMS.
* Manage and respond to breakdowns and unplanned maintenance requests via the CMMS, ensuring timely resolution and accurate documentation.
* Plan and schedule maintenance tasks in line with site priorities and CMMS workflows.
* Manage the scheduling and coordination of calibration activities via the CMMS, including planning, tracking, and reporting, with calibration execution delivered by internal or external providers.
* Contribute to the management of engineering budgets and critical spares.
Projects & Contractor Management
* Support facilities and utilities aspects of site capital projects, including installation, commissioning, and handover.
* Coordinate and supervise external contractors delivering maintenance and support services.
* Issue, control, and close work permits in compliance with site EHS permitting requirements, ensuring safe execution of contractor and internal works.
Compliance, Quality & Safety
* Carry out all activities in compliance with cGMP, data integrity, GDP, and site procedures.
* Complete GMP documentation (including work orders, deviations/issues, change controls, CAPAs, and audit actions) accurately and to a right-first-time standard.
* Provide technical training and guidance to operations and engineering colleagues on facilities, utilities, procedures/SOPs, and the effective use of the CMMS, in line with GMP requirements.
* Maintain compliance with statutory, regulatory, safety, and quality requirements across facilities and utilities.
* Author, review, and update engineering procedures and SOPs relevant to facilities, utilities, and maintenance activities, in line with GMP requirements.
* Complete all required training before undertaking tasks and in line with GMP expectations.
Continuous Improvement & Collaboration
* Identify and support the implementation of technical and working practice improvements to enhance reliability and reduce cost per unit.
* Build effective working relationships across operations, quality, and project teams to remove barriers and improve responsiveness.
* Contribute to a culture of continuous improvement, safety, and quality excellence.
Knowledge, Skills & Experience
Essential
* Demonstrable experience in facilities, maintenance, or process engineering within a regulated manufacturing environment.
* Experience working in a cleanroom or controlled environment.
* Good working knowledge of building services and cleanroom utilities (e.g. HVAC, compressed air, gases, utilities).
* Experience planning, scheduling, and managing maintenance activities using a Computerised Maintenance Management System (CMMS).
* Experience coordinating calibration schedules within a CMMS environment.
* Proven experience managing contractors, issuing work permits, and responding to breakdowns and unplanned maintenance.
* Ability to work independently while escalating issues appropriately.
Desirable
* Experience in a pharmaceutical, biopharmaceutical, or ATMP manufacturing environment.
* Experience using Maximo CMMS.
* Knowledge of calibration methodologies and compliance expectations.
* Experience contributing to deviation investigations and root cause analysis within a GMP environment.
* Experience maintaining asset data, spare parts, or equipment hierarchies within a CMMS.
* Experience supporting utility commissioning, requalification, or periodic review activities.
Qualifications
* Degree in an engineering discipline or recognised trade qualification with relevant experience.
* Strong understanding of pharmaceutical regulatory requirements and Health & Safety legislation.