Facilities Maintenance Engineer

About MeiraGTx

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). The facility is planned to manufacture to make Phase 3 and
commercial supply for its in-house programmes. The facility requires an asset Facilities engineer to assist the
engineering manager with the co-ordination of the day to day asset care requirements and performance
improvements, to the range of utility services and manufacturing equipment across the site.
This is a fast track programme, therefore the role requires the ability to be flexible and covers a very broad remit.

Major Activities

  • 5 -7 years minimum working in a highly regulated environment, planning, execution and supervision of
    Facility, Process or Maintenance engineering.
  • Min 3 years working in a Biopharma Cleanroom facility.
  • Supporting Site Capital Projects from a Utility and Facility Installation , Commissioning Perspective.
  • Oversee service contractor activities for PPM and reactive maintenance, including managing EHS permitting
    requirements in line with site procedures.
  • Assist with the continuous development and implementation of the internal and external PPM schedule, and
    ensuring adherence to it.
  • Ability to develop maintenance procedures, Plan, schedule and execute PPM and reactive maintenance as
    required.
  • Maintain all current statutory, regulatory and company safety and quality standards.
  • 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 requirements.
  • Develop and manage strong relationships across teams to remove barriers and time lags.
  • Assist with the identification and implementation of technology based and working practice solutions
    designed to reduce the overall cost per unit measures.
  • Assist with the development and maintenance of the engineering budget and and critical spares stock list.
  • Knowledge of Calibration methodologies and planning is desirable.

Key Performance Indicators

  • Improving Key Performance Indicator’s for building utilities services; equipment availability and
    performance; safe and quality compliant facility operations.
  • 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 environment.

Key Job Competencies

  • Comprehensive practical and theoretical background on a wide range of industrial plant and cleanroom
    services and utility equipment.
  • Proven experience in implementing engineering techniques – typically compressed air, Oxygen, H.V.A.C. and
    Utility systems applied to both general industrial and clean room standards.
  • 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.

Job Background

Education

  • Qualified to Degree in an engineering discipline or Trades Certificate

Experience

  • Management of safety requirements of Pharmaceutical Regulations and Health & Safety Executive, as
    defined in MeiraGTx procedures.

Cad Technician / Engineering Systems Controller

About MeiraGTx

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

Act as the Cad Technician and Engineering System Controller for MeiraGTx Shannon, ensuring that site drawings, engineering specifications are maintained  appropriately according to relevant procedures.

Support Project activities to update and maintain engineering drawings and documents as required.

Support the Engineering team in other Project and operational activities where requested.

Major Activities

  • Drawing Management: Update Engineering Drawings to the MeiraGTx drawing format once received from vendors and design consultants.
  • Developing a document control plan: Document receipt, filing, issuance and release procedures.
  • Document Control tasks including:
    • Tracking of both the receipt and issuance of all documents and reporting on the approval status, location of all Engineering documents at all-times.
    • Receiving all Engineering documents
    • Printing and issuing any electronic documents needed by the external consultants, Commissioning, project Teams.
  • Managing the approval process for all documents including:
    • Routing all Commissioning related documents for approval (e.g. DocuSign)
    • Managing the approval process by sending the document to agreed reviewers/ approvers according to the agreed approval matrix.
    • Managing and tracking the location/ person with whom each document sits at all times.
    • Reviewing all received documents for GDP including, ensuring all documents and files are clearly labelled and indexed and that this information is consistent with the MeiraGTx system numbering and naming system.
    • Ensuring all binders are complete with no empty or incomplete sections.
    • Ensuring all information is readable and neat with no damage, legibility issues.
  • Receiving and managing all electronic documents for GDP including:
    • Setting up and maintaining engineering library in electronic and hard file system as required.
    • Developing an electronic document control plan for the Engineering
    • Filing all MeiraGTx and external electronic documents in a neat and consistent manner
    • Logging/registration of all documents being printed, issued, received and stored.
    • Managing the electronic document control storage.
    • Managing the electronic approval process for all electronic documents
    • Reviewing all received electronic documents for GDP
  • Author and maintain procedural documents related to management of drawing and engineering documents
  • Support Periodic System Reviews as required of the drawing management system
  • Provide Key Performance Indicator Reports for departments as required.

Key Performance Indicators

  • The Drawing register is maintained up to date.
  • All users are appropriately trained and supported when accessing drawings and other engineering documents
  • Attend any required training as defined by line manager
  • Metrics Reports are accurate and provided in a contemporaneous manner as required

Key Job Competencies

  • Experience in working with and maintaining Drawings and other engineering documentation
  • Fully computer literate, proficient with standard software packages on an advanced level (such as Microsoft applications, specifically Excel, Word, Powerpoint) and adaptable to new software packages / web applications
  • Excellent interpersonal skills
  • Good organisational and time management skills and able to demonstrate flexibility and adaptability
  • Experience working with high volumes of documentation, electronic and paper
  • Good attention to detail for data entry tasks and understanding of Good Documentation Practices
  • Experience and knowledge of working in a regulated environment, specifically with regards to record retention

Job Responsibilities

  • No direct reports

Job Background

  • Minimum of 3 years experience working in a GxP environment
  • Knowledge of GEP and GMP in relation tp pharmaceutical projects
  • Profecient in using CAD Design software, Autodesk, Revit, BIM ect
  • Ability to read and translate blueprints and technical drawings.
  • Understanding of building design and mechanical processes.
  • Ability to work as part of a team and individually on projects.