Your mission Provide subject matter expertise in the establishment, improvement, troubleshooting and execution of maintenance and calibration activities, to ensure that assets required for the GMP manufacture and testing of gene therapy products are available and fit for use in line with business requirements Job Description Major Activities SME for Calibration, Metrology and Planned Maintenance techniques and requirements Responsible for defining the optimum approach for maintenance and calibration of GMP assets, based on technical knowledge and cGMP requirements/best practice Responsible for coordinating technical oversight and approval of calibration and maintenance technical documentation (internal and external) throughout the equipment lifecycle Responsible for the coordination and supervision of maintenance and calibration activities by internal and external resources in accordance with the CMMS. Responsible for creation, review and approval of maintenance and calibration technical documents for new equipment introduction and throughout the equipment lifecycle Responsible for technical input into new/revised Service Level Agreements with 3 rd parties for calibration and maintenance Responsible for authoring and maintaining Technical Standards relating to calibration and maintenance, in partnership with other Calibration & Maintenance Engineers Responsible for demonstrating a high standard of health and safety behaviour and practice, ensuring that all EHS commitments are delivered on time in full Responsible for supporting a state of Inspection Readiness every day within the Facilities and Maintenance Engineering team, and for supporting the successful preparation and fronting of Regulatory Inspections and Audits Manage Quality processes including Risk Assessments, Change Controls, CAPAs and Deviations as per the site Quality Management System, including as lead for deviations relating to maintenance as-found failures. Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures Responsible for ensuring that own training is undertaken in a timely and GMP-compliant manner before the task is undertaken Responsible for ensuring that any GMP documentation assigned, e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions, is closed in a timely manner and in a RFT state that complies with MeiraGTx procedures, including Health and Safety and GMP Responsible for identifying, collaborating and delivering continuous improvements within the Facilities & Maintenance team to improve safety, quality, service and cost Key Performance Indicators Planned Preventive Maintenance and Calibration timeliness Timely response to unplanned maintenance requirements Timely completion of all Safety and Quality commitments Key Job Competencies Subject Matter Expertise in Calibration, Maintenance and/or Metrology Job Responsibilities Supervision of internal and external personnel performing planned maintenance Responsible for approving master documentation and executing documentation as SME Responsible for fronting as SME in regulatory inspections regarding Calibration and Maintenance Job Background Experience performing and/or supervising maintenance in GMP operational facilities Experience with Computerised Maintenance Management Systems HNC / HND / Degree level education in a relevant Engineering discipline Excellent standard of written and verbal communication in the English language 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.