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.
Purpose of Job
As MeiraGTX begins its journey in automation and Digital Data Analytics, MeiraGTx is looking for a bright, ambitious Automation Engineering Leader who can quickly build up our internal expertise in our current “Operational Technology” systems, to improve system robustness and reduce our dependency on specialist suppliers and someone who can work across all functions to create a multi-year “Roadmap to Pharma 4.0” to enable phase appropriate construction of the company’s automation and DDA capability for Senior Executive endorsement and subsequent implementation across Ireland and London.
They will be responsible for designing, developing, implementing, and maintaining industrial computerized process control and process monitoring systems (SCADA, PLC and HMIs) in a biopharmaceutical manufacturing cGMP environment for MeiraGTx in both London and Ireland.
They will become MeiraGTx’s technical expert in our current control systems (including SACDA, PLCs, EMS, BMS) to enhance reliability and recommend and implement practical improvements.
As such they will relish the range of accountability from hands on trouble shooting on the front-line to developing multi-year strategic plans for implementation in line with the development of our two GMP manufacturing sites and the growth of our later stage clinical pipeline.
They will write and/or review user requirements, functional requirement specifications, automation equipment qualification protocols, enterprise or system interfaces, process development reports, and provide technical assessments, rationales and approval for engineering and process changes to meet regulatory requirements. You will work with the Process Development, Manufacturing and Quality teams to design and implement automation to MeiraGTx’s Gene Therapy manufacturing platforms as these emerge from Process Development and are transferred and scaled for Late Stage Clinical and commercial manufacturing. processes you will support automated equipment qualification and draft documentation for regulatory filings to advance MeiraGTx’s product portfolio.
- Collaborate closely with site and global stakeholders to define and deploy automation solutions including equipment, processes, and manufacturing execution systems
- Translate business, technical, and regulatory requirements into systems-level solutions during development and deployment of automated processing technologies
- Manage technical work streams with cross-functional stakeholders throughout entire project lifecycle, from concept to implementation
- Lead and participate in evaluation of new technology and process automation for introduction into GMP manufacturing
- Responsible for the site PLC-based Control System, Building Management Systems, and Environmental Monitoring System, including monitoring, maintaining, trouble shooting and investigating control system hardware, wiring, and instrumentation.
- Develop, review and/or approve Preventive Maintenance Plans, Standard Operating Procedures, IQ/OQs, commissioning protocols, user requirement specifications, acceptance test plans, Functional Specifications, Design Specifications, and drawings and diagrams.
- Work with site Quality and Computer System Validation personnel to ensure automation and control system GMP compliance.
- Implement and complete change controls, CAPAs, and Deviations for automated GMP systems and equipment.
- Proactively search for and implement innovative solutions to improve system performance, reliability, and compliance.
- Support training efforts for new equipment installations
- Bachelor’s degree in Engineering from an accredited university in mechanical, chemical, or electrical disciplines with 5+ years’ experience supporting or developing automated systems.
- Strong understanding of automation standards and architecture addressing batch process control, such as S88, and related automation systems, including process control systems, manufacturing execution systems, process data historians, and laboratory information management systems
- Experience in pharmaceutical/ biopharmaceutical drug substance manufacturing environments and processes.
- Proven programming and maintenance experience with PLCs and Software applications, ideally across a number of industrial platforms
- Knowledge of Building Management/Automation Systems
- Experience with supporting and maintaining automation and control system infrastructure, including PLCs, remote I/O panels, BMS equipment, wiring and cabling systems, as well as proprietary equipment controllers and control systems
- Experience with various data communication protocols and architectures, including ControlNet, Ethernet I/P, Modbus, BACnet and/or Profibus
- Works and communicates well in a multi-discipline team structure
- Demonstrates skills in requirements gathering, design, configuration, integration, and implementation of process control solutions for the manufacturing industry including batch software, PLC based control systems, HMI packages, building management systems, SCADA systems, and PC networking technology
- Familiarity with FDA GMPs and FDA regulations relating to biologic and drug products
- Familiarity with FDA regulation 21 CFR Part 11 and/or EU Annex 11