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
The role is required due to MeiraGTx having set up its internal Manufacturing Facility for the manufacture of Advanced Therapies (Gene Therapy viral vectors) in Shannon. The facility is planned to manufacture Phase 3 and and commercial supply for its in-house programmes. The facility requires a Process / Project engineer to 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. Support capital and Tech Transfer projects across the site.
This is a fast track programme, therefore the role requires the ability to be flexible and covers a very broad remit.
- Support Capital project design and review
- Support Product technical transfer and Process qualification activities
- Oversee service contractor activities for maintenance, Calibrations, Comissioning and Qualification
- Assist with the continuous development and implementation of the internal and external Engineering sopecifications and procedures.
- Carry out PPM and reactive maintenance as
- Maintain all current statutory, regulatory and company safety and quality
- Assist with the implementation, maintenance and measurement of a framework for compliance and ongoing improvement in quality performance and right first time culture within the facilities and engineering
- area. This will be in accordance with statutory, regulatory and company standards, procedures and systems regarding relevant cGMP, Quality Systems and Health and Safety in the workplace.
- Ensure the availability and reliability of building utilities, services and manufacturing equipment for the operational areas, in order that they can achieve the plans to satisfy customer
- Develop and manage strong relationships across teams to remove barriers and time
- Assist with the identification and implementation of technology based and working practice solutions designed to reduce the overall cost per unit
- Assist with the development and maintenance of the engineering budget and and critical spares
Key Performance Indicators
- Improving Key Performance Indicator’s for building utilities services; equipment availability and performance; safe and quality compliant facility
- Supporting project deliverables delivery on
- Development of an asset care strategy and growing profitability through reducing the cost per unit measures
- The individual must have a track record in working in a cleanroom
Key Job Competencies
- Comprehensive practical and theoretical background on a wide range of Biopharmaceutical and pharmaceutical Process, cleanroom and utility
- Proven experience in implementing engineering design and installation activities – typically compressed air,
- H.V.A.C. systems, supporting Utilities, applied to both general industrial and clean room standards.
- Min 8 years experience working with mechanical services in a manufacturing
- Min 5 years Experience of working within a Biopharmaceitical environment in a project or Plant engineering
- Experience with the requirements of commissioning and qualification of Facility equipment in a pharmaceutical
- Experience with Fill Finish operations in Biopharmaceutical operations is
- Problem Solving – Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional
- Leadership – exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to
- Cost Consciousness – works within approved budget; develops and implements cost saving measures; contributes to profits and revenue; conserves organizational
- Motivation – sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence;
- Planning/Organizing – prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules other people and their tasks; develops realistic action plans.
- Professionalism – approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on
- Quality Management – looks for ways to improve and promote quality; demonstrates accuracy and
- Innovation – displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and
- Oral Communication – speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in
- Written Communication – writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written
Qualified to Degree in an engineering discipline.
- Management of safety requirements of the HPRA/F.D.A. and Health & Safety Executive, as defined in MeiraGTx