Cad Technician / Engineering Systems Controller
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.
- 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
- No direct reports
- 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.