Responsibilities

• Reporting to the MES Lead, The MES Engineer will have responsible for supporting the delivery of an expansion to existing MES system (Werum PasX).
• The MES engineer will participate in the development of key AIT quality documents, such as Quality Assurance (QAPs) test plans, Quality assurance summary reports, ensuing adherence to all Automation documentation.
• This candidate will be required to work closely with the site AIT teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.
• This candidate will review and ensure vendors compliance with site quality standards.
• He/she will represent the MES function at AIT and other site project meetings, 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 QAIT (Quality) function and ensure their requirements are met in all deliverables
• Generate and Execute AIT 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
• Shift work maybe introduced and if so, you will be expected to work shift hours. Shift pattern will be open to change depending on business requirement.

Qualifications & Education

• Experience in a similar role, ideally in the Pharmaceutical industry.
• Expert knowledge of GAMP5.
• MES Werum PasX OSI PI.
• Relevant Computer Science or Engineering degree or equivalent

To apply contact Martin Lynch on 087-344 3581.

Email CVs to mlynch@mile.ie