15771 – Automation Engineer IV – Meath Contractor

This is an 11- month contract .

Purpose:

Reporting to the IT BioNX Project MES Lead, specifically responsible for MES Systems (Werum PasX). This candidate will be required to work closely with the IT teams responsible for the full Automation and IT scope and with vendors/partners with responsibility for delivery of systems.

Responsibilities:

• Develop and/or review System Development Life Cycle (SDLC) deliverables, compliant with Company standards.
• Work within MES project team in the 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 Company 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.
• Participate in, and support, relevant project meetings.
• 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.
• Other duties as assigned.

Minimum Qualifications & Requirements:

• 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).
• The technical proficiency of MES applications (preference Werum PAS-X).
• 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.