Reporting to the MES Lead, The MES Engineer will be responsible for supporting the delivery of an expansion to existing MES system (Werum PasX). You will participate in the development of key quality documents, such as Quality Assurance (QAPs) test plans, Quality assurance summary reports, ensuing adherence to all Automation documentation. You will be required to work closely with the AIT 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. Represent the MES function at 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.
- Develop templates for all SDLC deliverables, compliant with standards, to ensure consistent implementation of the validation 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
- Liaise with the various stakeholders on the overall project to ensure clear communication between all parties in relation to AIT validation requirements.
Qualifications & Education
- Minimum of 3 years’ experience in a similar role, ideally in the Pharmaceutical industry.
- Expert knowledge of GAMP5.
- Strong experience in one or all of the following systems: MES Werum PasX OSI PI.
- The successful candidate may sometimes be required to attend meetings at other sites or Vendor sites.
- 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 firstname.lastname@example.org
|Job Category||MES Engineer|