Your mission
The Senior IT Site Engineer will be primarily responsible for managing the daily operations of local IT systems and infrastructure in the Shannon Ireland site, while also providing support to all users on site and assisting all departments in managing their IT systems. Additionally, the role will involve providing support and collaboration to other MeiraGTx locations as needed.
The Senior IT Site Engineer will have the important responsibility of ensuring that all Site IT systems are functioning properly and in compliance with applicable regulations. They will also be involved in developing IT-related policies and procedures for all local IT resources and managing the IT requirements of the company's expanding office.
Job Description
Major Activities
- Provide Level 2&3 support to troubleshoot desktop and user-related issues.
- Offer complete technical support for implementing all manufacturing and laboratory systems on-site, working in conjunction with other relevant departments on the site.
- Provide second and top tier technical support to all sites for escalated Tier One IT issues such as file, print, hardware, network connectivity, and software errors.
- Maintain an inventory of IT equipment and keep the assets register up-to-date.
- Manage vendor interactions in relation to service level agreements, tickets, and IT support issues.
- Maintain records of software upgrades and newly installed computer equipment, ensuring that licensing for all purchased software is recorded and maintained.
- Be an active participant in global groups to manage, update, and upgrade systems like Active Directory, antivirus systems, networks, app deployment, helpdesk and infrastructure.
- Ensure continuous improvement culture in managing lifecycle and deploying hardware, software, and systems used on-site.
- Assist in the development and management of Microsoft Cloud Systems, such as MDM and Intune, as well as AAD and M365.
- Collaborate with the IT Site Manager to document corporate and local IT policies and procedures related to systems, users, user and data security.
- Ensure that all work complies with GMP, Data Integrity, and Good Documentation Practice (GDP) and is conducted and documented in accordance with applicable procedures.
- Create, review, and execute GAMP Protocols for onboarding, updating, or maintaining GXP Systems (CR, IQs, OQs, PQs, Reports, etc.).
- Ensure timely and RFT (Right First Time) closure of any GMP documentation assigned, including but not limited to issues, CAPAs, change controls, BMRs, and audit/inspection actions.
Key Performance Indicators
- Ensure all systems are operational to enable them to work efficiently.
- Ensure all staff are appropriately trained on legislative IT items and company policies / procedures.
- Recommend improvements in IT applications / set-up.
- IT assets are accounted for and logged in an appropriate manner.
- Successful implementation of IT system for new manufacturing facility.
Key Job Competencies
- Excellent documentation skills, preferably in a GxP environment.
- Ability to manage backup solutions such as Veeam.
- Strong project management skills and the ability to solve problems in a methodical manner.
- Ability to interact with other departments and personnel across the organization, demonstrating strong interpersonal and customer service skills.
- Capacity to identify and escalate issues to line management, ensuring that workload is prioritized and issues are highlighted to meet business needs.
- Flexibility and adaptability to respond to the needs of the business, demonstrating good organization and time management skills.
- Understanding of team dynamics and the ability to work both independently and as part of a team without direct supervision (self-starter).
- Experience working with Validated Computerized Systems (GxP) is preferred.
- Experience with network security and network tools (certifications preferred).
- Excellent communication skills.
Job Background
Education (High School or equivalent)Cisco certifications preferred or equivalent work experience
- Cisco Certified Entry Networking Technician (CCENT)
- Cisco Certified Technician (CCT)
- Cisco Certified Network Associate (CCNA)
- Cisco Certified Design Associate (CCDA)
- CompTIA Network+ (non cisco)
Microsoft certifications preferred
- Microsoft technology associate (MTA)
- Microsoft MCSE (certified solutions expert)
Experience- Experience working in a GxP regulated industry (3+ years) is advantageous.
- Or in-depth knowledge and working experience of ITIL processes (3+ years).
- Strong background or experience in Microsoft Systems, including AD, LDAP, etc. (3+ years).
- Strong background in Networking Systems Administration (3+ years).
- Preferred experience with hybrid Azure/on-prem file server, AD configuration.
- Organizational and project planning skills.
- Excellent relationship-building skills, with a "can-do" attitude.
- Exceptional communication skills, including the ability to confidently converse with people and translate technical information for end-users.
- Enthusiastic, self-motivated, and flexible individual able to work independently and unsupervised.
About us
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.
