Headcount Solutions is seeking a Senior MES Engineer for our client’s biologics facility in Meath/West Dublin.
Reporting to the Project MES Lead, specifically responsible for MES Systems (Werum PasX), this person will be part of a team responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.
- Develop and/or review System Development Life Cycle (SDLC) deliverables, compliant with client standards.
- Work within MES project team in development of systems specifications including integration with other systems, electronic batch record specifications to cover on-site processes and operational specifications for manufacturing.
- Work closely with the QAIT function to ensure compliance with client Quality standards.
- Participate in MES design workshops with MES Vendors, site integrators and site representatives.
- Participate in the delivery and qualification of the MES Design to meet operational readiness timelines.
- Liaise with relevant stakeholders to lead and design on the overall project deliverables and to ensure clear communication between all parties.
- Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
- Bachelor’s Degree in Engineering, Information Systems, Computer Science or the Life Sciences.
- Fluent in English, written and verbal.
- Minimum of 7-10 years’ experience in a similar MES role, ideally in the Pharmaceutical industry.
- Experience in the commissioning and qualification of MES on site in a GMP manufacturing environment.
- Experience in MES integration with other Level 2 & Level 3 systems and lead design and qualification, implementation on a greenfield site will be advantageous. (preference DeltaV).
- Technical proficiency of MES applications (preference Werum PAS-X).
For further information please contact Michael on 086-0435195 or forward details in confidence to [email protected]