Orion Group Life Sciences are currently recruiting an MES Engineer on behalf of our Multinational Biopharmaceutical Client based in Mayo on an initial 12-Month contract with potential to extend.
Purpose
* Maintain the MES (POMSnet) environment; to author & maintain recipes & worksheets for Westport site.
* Troubleshoot and provide solutions for MES & SAP problems in recipe execution and recipe authoring.
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 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 2 years authoring experience preferably using POMSnet.
* Be familiar 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 an advantage.
* Proven attention to detail and mental concentration, to ensure total compliance with procedures at all times.
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