Job Description
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. #J-18808-Ljbffr