Responsibilities

• MES Project Engineer will be part of the site project team delivering Automation and IT systems required for new Green Field facilities.
• Reporting to the site Project Manager, specifically responsible for delivery of expansion to existing MES system (Werum PasX)
• The MES engineer will lead the development of key MES quality deliverables, such as Quality Assurance (QAPs) test plans, Quality assurance summary reports, ensuring adherence to site standards and procedures.
• This candidate will be required to work closely with the site Project teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems
• Review and ensure vendors compliance with site quality standards
• MES project engineer will represent the MES function at project level and will report progress to AIT team, project tier level and site level as required
• Develop and maintain Qualification Plans and Test Plans, aligned with the overall project C&Q plan and with the leveraging strategy
• Work closely with the DDQ (Quality) function and ensure their requirements are met in all deliverables
• Align with the site program: leverage existing documents & expertise where feasible
• Approver of all AIT MES SDLC deliverables, ensuring compliance with standards
• Provide FAT oversight and perform leveraging assessments
• Provide guidance and support to AIT team members tasked with delivery of SDLC documents
• 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

Qualifications & Education

• Experience in a similar role, ideally in the pharmaceutical industry (experience in Pharmaceutical OSD and/or API experience would be advantageous)
• Expert knowledge of GAMP5
• Required, strong experience in the following systems: Werum Pas-X
• Advantageous, experience in the following systems: OSI PI
• The successful candidate may sometimes be required to attend meetings at other sites off-site or at vendor offices within Ireland
• Excellent computer skills, proficient in the use of the following Microsoft tools: Excel, SharePoint, Word and PowerPoint
• Strong interpersonal and communication skills (verbal and written)
• Relevant Computer Science or Engineering degree or equivalent

To apply contact Martin Lynch on 087-344 3581.

Email CVs to mlynch@mile.ie