MES Project Engineer

Contract
Tipperary, Ireland
Posted 9 months ago
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
Job Features
Job Category | MES Project Engineer |