MES Operations analystSummary: An MES Operations analyst is required to join a leading biotechnology manufacturing company. This position offers an impressive and unique opportunity for interested candidates. This position requires people who want to be challenged, have a passion for success, and a constant drive to exceed expectations. Responsible for the Design and Configuration of the Manufacturing Execution Systems (MES) manufacturing Batch Records and Equipment data. The successful individual is responsible for eliciting and documenting manufacturing business processes requirementsEssential Duties and Responsibilities:Design and deploy MES system (Werum's PAS-X) to replace paper based process or manual processes in the processing areasCoordinates the needs of functional departments and establishes priorities for MES User requirements gathering, system design and implementationActively participate in project deliverables such as Review of company documentation including SOPs, Batch Sheets and/or Manufacturing Records to assess requirements for designing electronic recordsDesign and develop MES recipes, workflows, Equipment, Master Data and electronic batch records to meet the requirements of the Business, specifically Manufacturing and QAParticipates in the Creation and Testing of MES related protocolsResponsible for maintaining MES design documentation in a state compliant to GAMP 5 throughout the system's life cycleProcesses system change control, documents configuration, and writes test plans to ensure that the MES remains in a validated stateLiaise with Technical Trainers to develop training plans for MES usersProvides end-user support for the MES including troubleshooting problems on the floor and work closely with IT to troubleshoot problemsImplement strategies to improve process efficienciesKnowledge and Skills:Knowledge of BioPharma Manufacturing and Supply Chain ProcessKnowledge and experience of MES preferably Werum PAS/XIn depth knowledge of concepts of GMP, ICH guidelines and GAMP requirementsAn understanding of the project lifecycle and of quality management processesLogical troubleshooting and problem solving skillsExcellent analytical, written and oral communication skillsCore Competencies: BS/BA/BEng in a Technical Discipline required, with 0-2 years of experience working within a Life Sciences manufacturing environment. Will substitute relevant industry experience in lieu of educational requirementInterested?Contact Dan on (01) 645 5250 or click "apply"