Your mission
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.Job Description
Key Responsibilities Facilities, Utilities & Asset CareDeliver 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 ManagementSupport 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 & SafetyCarry 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 & CollaborationIdentify 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 EssentialDemonstrable 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.DesirableExperience 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.QualificationsDegree in an engineering discipline or recognised trade qualification with relevant experience.Strong understanding of pharmaceutical regulatory requirements and Health & Safety legislation.About us
MeiraGTx is a clinical-stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases. We currently have six programs in clinical development including three ocular indications, a salivary gland condition, and a Parkinson's disease program. Our initial focus on diseases of the eye, salivary gland and central nervous system is based on the significant unmet medical need coupled with the high potential gene therapy has to provide meaningful clinical benefit in these areas. With headquarters in New York and London, our global footprint provides us the opportunity to partner with leading institutions around the world, allowing us to deepen our understanding of diseases and their progression.Our team was built with deep expertise in gene therapy development, allowing us to efficiently advance our programs from preclinical to clinical development. Our core capabilities in viral vector design and optimization and gene therapy manufacturing give us a differentiated approach to developing gene therapies. Additionally, we are developing proprietary technology to potentially enable innovative gene therapy treatments whose expression can be turned on and off with an easily administered small molecule. We believe temporal control of gene therapy products has the potential to transform the gene therapy landscape.Our state-of-the-art manufacturing facility, completed in early 2018, was designed to meet global regulatory requirements, including the current good manufacturing practices (cGMP) required by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the U.S. Food and Drug Administration (FDA). The 29,000-square foot facility has the flexibility and capacity to produce sufficient product for all our clinical trials and will scale to commercial capacity.