Assoc Manufacturing MES Specialist (Days) - Regeneron Pharmaceuticals, Inc
  • Munster, Munster, Ireland
  • via ClickaJobs (1)
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Job Description

Within this role you will be responsible for leading the deployment and support of the Manufacturing Execution Systems (MES), Manufacturing Batch Records (MBRs), Generic Manufacturing Batch Records (GMBRs) and Equipment data.As a Manufacturing MES Specialist a typical shift might include, but is not limited to, the following:Chair reviewing and approving sessions of MES project deliverables against the overall project planMES Design Spec reviewing using the MR/BS and completed design spec/process flow map templatesPopulating and completing review of MES documentation such as Config Spec (MESCS) and Trace Matrices (TMs)Leading Pre-PE executions (Static and Dynamic) and testing of MES recordsCoordinating team on plant testing (Shakedowns) of MES documents with MFG SMECoordinating team and documentation of all testing protocol and ensure GDP and complianceCoordinating of Workflows for documentation approvalReviewing of data for build of OPM recipes to support the MES buildCoordinating of MES Deployment Support – documentation readiness and change control supportCoordinating with area owners to ensure Process Area readiness for MES Deployment (hardware, barcoding etc.)Coordinating of sustaining deployed MES records to ensure timely close-out of executed MES recordsLeading MFG element of launch activities in the lead up to MES records live on the production floorLeading coordination of hypercare activities as part of wider MES team live on the production floorThis role might be for you if:You demonstrate knowledge and experience of MES preferably Werum PAS/XYou possess logical troubleshooting and problem-solving skillsYou have excellent analytical, written and oral communication skillsYou demonstrate an ability to work within a successful teamTo be considered for this opportunity you should have a BS/BA/BEng in a technical discipline, with 0-2 years of experience working within a Life Sciences manufacturing environment or equivalent combination of education and experience. #J-18808-Ljbffr

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