Responsibilities

• Ensure the appropriate quality documents as needed for the Life-Science industry, such as Quality Assurance (QAPs) test plans, Quality assurance summary reports (QASR) are in place and aligned with the qualification strategy of the project.
• Required to work closely with team members both global and local, having responsibility for the full IT scope, and liase with vendors and trade partners on delivery of systems.
• The candidate will review and ensure vendors compliance with site quality and hardware standards.
• The IT Workstream lead will drive the development and provision of all IT active equipment.
• Manage the provision and configuration of Shop Floor Hardware components such as HMI’s, OIT’s, Label Printers, Bar Code Scanners, and other hardware devices required in manufacturing or support areas.
• Working with peers in the manufacturing business to understand and capture their IT Requirements and assist in the provision of same.
• Liaise with the global COE (Centre of Excellence)teams and lead the development, configuration / installation of the Audio Visual (AV) requirements for conference/meeting rooms, and common area AV requirements as defined by the Business units.
• Project Planning, and adherence to schedule in conjunction with the Scheduler and Workstream Leads
• Utilisation of Project management tools including Risk, Issue, Action and Decision management
• Assess the needs of the process, applications, environment, and users, to develop a shop floor hardware infrastructure for use in a sterile manufacturing facility and supporting areas.
• Coordinate with trade partners on design and installation of communication support rooms across the facility
• Develop SDLC deliverables, compliant with site standards, to ensure consistent implementation of hardware devices and AV components.
• Align with the site Global IT standards: leverage existing hardware designs, documents & expertise where feasible.
• Provide guidance and support to AIT team members tasked with delivery of key systems.
• Provide input to the development of realistic project schedules and document trackers.
• Work closely with suppliers / integrators to ensure compliance with site standards
• Participate in, and support, relevant project meetings
• Liaise with the various stakeholders on the overall project to ensure clear communication between all parties in relation to AIT validation requirements.

Education

• Expert knowledge of GAMP5.
• Understanding of manufacturing execution and control systems as well as warehouse and material management systems to deliver appropriate IT support tools.
• Excellent computer skills, proficient in the use of the following Microsoft tools: Word, Excel, PowerPoint, Viso, MS Project and Agile PM tools.
• Relevant Computer Science or Engineering degree or equivalent

To apply contact Martin Lynch on 087-344 3581.

Email CVs to mlynch@mile.ie