Senior Mes Engineer

1 week ago

Westport, Ireland Quanta Consultancy Services Ltd Full time

Senior MES Engineer - Ireland, Westport - 12 Months Contract
Located on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for a Senior MES Engineer to join their state-of-the-art pharmaceutical facility.
They have invested $55 billion in research to discover and develop new medicines in the pursuit of scientific breakthroughs and changing people's lives.
They have 50,000 employees around the world and are continuing to grow.
Essential duties and responsibilities
Design, create, write and/or make all required changes to MES Recipes, worksheets, equipment and material specs including phase transition logic
Design, create, write and execute, test and validation protocols, risk assessments, and system documentation
Design, create, write and/or make all required changes to ensure cleaning, equipment and product procedures are aligned to MES processes and vice versa
Design, create, write and provide training for all other site personnel on their related MES roles and arrange system access
Participate in MES knowledge exchanges, MES Governance meetings, and manage issues, work-around and fixes identified
Provide support to other MES system users as required to ensure business continuity
Participate in NPI projects from initiation to ensure MES system or hardware requirements are taken into consideration
Keep other recipe authors up to date on MES changes
Documentation of all activities in line with cGMP requirements
Cross training within the team and training of new team members
Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems
Adheres to and supports all EHS standards, procedures and policies
Desirable Experience
Third Level qualification in suitable manufacturing, engineering or business course and/or suitable experience
Extensive authoring experience and has led or was technical lead on multiple implementation projects
Be proficient with MES application and configuration rules and requirements including interfacing (preferably POMSnet)
Experience of batch processing operations in an FDA/HPRA regulated industry.
Strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry
A good knowledge of IT systems is required for this role
SAP knowledge/experience in MM, PP and IM modules
Proven attention to detail and mental concentration, to always ensure total compliance with procedures
If this role is of interest, please apply now
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