Senior Mes Engineer

2 days ago

Sligo, Sligo, Ireland Gertek Project Management Full time

Location - Westport, Mayo GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services.
We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects.
Role title - MES Engineer (Senior) - Westport Overview: Maintain the MES (POMSnet) environment; to author and maintain recipes and worksheets for the Westport site.
Provide technical guidance and solutioning to other MES Engineers.
Act as site escalation point for complex or challenging troubleshooting or recipe design.
Provide project management guidance and expertise to the MES function.
Responsibilities: Design, create, write and/or make all required changes to MES Recipes, worksheets, equipment and material spec's 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-arounds and fixes identified.
Liaise with the Global MES on Westport requiring system improvements.
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.
Requirements: Third Level qualification in suitable manufacturing, engineering or business course and/or suitable experience.
A minimum of 7 years authoring experience and has led or was technical lead on multiple implementation projects.
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.
SAP knowledge/experience in MM, PP and IM modules.
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