- 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 email@example.com
|Job Category||Manufacturing Execution System (MES), MES Engineer|