MES Engineer II
Team Horizon is seeking a MES Engineer for our client who are a global leader in the biopharmaceutical industry for their Mayo site.
The purpose of this role is to maintain the MES environment; to author and maintain recipes & worksheets. As well as troubleshooting ad providing solutions for MES and SAP problems in recipe execution and recipe authoring.
Why you should apply:
* This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
* There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people's lives.
* Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
* 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 the sites 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.
What you need to apply:
* 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