MES ENGINEER

at  Ralta Technologies RT

Réalta Technologies is a leading automation and digital system firm that specializes in delivering innovative solutions to clients in the life science industries. We are seeking a MES Engineer with Werum PAS-X to join our team and work with one of our pharmaceutical clients based in Dublin.

REQUIREMENTS

• Fluent in English, written and verbal.
• Minimum of 5 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.
• 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

• 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, including but not limited to:
• Requirements Specification
• Requirements Traceability Matrix
• Functional Specification
• Design Specification
• Code Review
• Test specification/test script
• Work closely with the DDQ function and ensure their requirements are met in all deliverables
• Align with the MES COE program: leverage existing documents & expertise where feasible
• Approver of all AIT SDLC deliverables, ensuring compliance with standards
• Provide FAT oversight and perform leveraging assessments,
• Provide guidance and support to Digital 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 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 validation requirements