Your mission
Support Process Technical transfer activities; including Design of Experiments, Single-Use items specifications development for manufacturing use and ongoing Process FMEA activities.Job Description
Major ActivitiesSupport capital and Tech Transfer projects across the site.Assist the Engineering Manager with the co-ordination of the day-to-day site operations/performance improvements, to the range of utility services and manufacturing equipment across the site.Coordination of vendor activities for Commissioning & Qualification, Maintenance & Calibration and/or process improvements.Assist in developing engineering work instructions and GMP procedures ensuring data accuracy.Actively involved in tracking, analyzing, and optimizing the lifecycle of critical assets, ensuring cost efficiency and regulatory compliance.Support on-site EHS programs including process and task risk assessments, investigations and/or any other related aspect of safety improvement performed by the process/facilities engineer.Assist with the implementation, maintenance, and measurement for continuous improvement. Exhibit a right-first-time ethos while sustaining compliance to statutory, regulatory and company standards, procedures, and systems.Collaborate effectively across multiple departments to ensure seamless execution of projects and compliance with regulatory standards.Develop and manage strong relationships across teams to remove barriers, while performing effectively within own working groups to achieve favorable outcomes for the business.Assist with the identification and implementation of technology based and work practice solutions designed to reduce waste and overall cost.Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDocP).Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner.Ensure that any GMP documentation assigned is closed timely and in a RFT state.Key Performance IndicatorsDeliver sustainable improvements exhibited via KPIs assigned to engineering and aligned with safety and quality compliance policies.Support project deliverables, including on-time and right first time (RFT) requirements.Contribute proactively to the wider development of an evolving engineering team and its effectiveness to add value in a setting focused on compliance and ultimately patients benefit.Reduce unplanned downtime by supporting proactive maintenance strategies and vendor coordination.Achieve positive feedback from stakeholders on communication, responsiveness, and ability to work cross-functionally to resolve engineering and maintenance challenges.Identifying and assisting in implementing process, technology, or safety improvements each quarter to enhance asset reliability, optimize operational costs, and strengthen compliance with GMP and SH&E standards.Ensure accurate and timely asset data entry, updates, and verification within the CMMS.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.