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MES Engineer

4 weeks ago

Sligo, Sligo, Ireland TN Ireland Full time

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• 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 Abbvie Global MES on Westport required 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.


• 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.

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.


• 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.

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