Commissioning and Qualification Engineer
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
This is a key role in the site commissioning phase MeiraGTx Manufacturing Facility In Ireland for the manufacture of Advanced Therapies (Gene Therapy viral vectors). The facility will manufacture plasmid and clinical material with the ambition of producting commercial supply in. The facility requires an C & Q Engineer to assist the Head of Engineering with the implementation and operation of the site commissioning plan.
This is a fast track programme, therefore the role requires the ability to be flexible and covers a very broad remit.
- Effectively working within a multidisciplinary team to Prepare, schedule and execute Commissioning and Qualification protocols
- Lead Risk assessments for process and equipment as required
- Develop system impact assessments, validation plans, protocols and reports that support the qualification and validation of systems.
- Execute Commissioning and validation of manufacturing equipment, downstream equipment and processes in addition to supervising and witnessing CQ carried out by vendors.
- Develop protocols for validation projects using a risk based approach that meets regulatory requirements and industry practices.
- Review and approve Layout development and review for material and personnel flow compliance
- Review analyze and interpret system performance data for completed validation and prepare final
- report packages by summarizing the data.
- Investigate deviations, write investigation reports and create summary reports.
- Promote cGMP and regulatory compliance into assigned projects.
- Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Strong trouble shooting and Safety compliance experience is escential for this role.
- BSc/MSc or BEng/MEng in Engineering or related discipline.
- 5 -7 years minimum in validation, quality systems, operations, engineering or any combination thereof.
- Experience in multiple GMP validation disciplines (process equipment, utility, automation, computer systems, sterilization) with advanced technical knowledge.
- Validation experience using risk based approach guidelines, international regulatory requirements and standards and other in.
- Experience interacting with or creating material for representatives of regulatory agencies and executive level staff.
- Experience with investigations into manufacturing deviations and determination of product impact potential, root cause and corrective actions.
Key Job Competencies
- Comprehensive practical and theoretical understanding of a wide range of industrial plant and cleanroom services and utility equipment.
- Proven experience in commissioning plant and equipment in a GMP environment
- 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 topics.
- 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 others.
- Cost Consciousness – works within approved budget; develops and implements cost saving measures; contributes to profits and revenue; conserves organizational resources.
- 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 commitments.
- Quality Management – looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.
- Innovation – displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas.
- 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 meetings.
- 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 information.