Senior MES Engineer

SimoTech requires a Senior MES Engineer, responsible for the delivery of new and updated Master Batch Records for use in production, for a Biotech project in Dublin. Candidates must have at least 5+ years’ experience in operations/manufacturing environment in the pharmaceutical / life sciences industry.

Key Responsibilities
  • Responsible for the development, configuration and testing of Master Batch Records (MBRs) from initial to final design.
  • To lead MBR development design reviews including liaising with Operations, Process Development and Quality functions.
  • Drafting, executing and reviewing Application Lifecycle Management test scripts and test sets for testing MBR design.
  • Supporting the ongoing development of the MES system in development of MBRs, as well as improving the MES business process.
  • Training of Electronic Batch Record (EBR) end-users (Supervisors, Operators, Technical/QA/Support staff).
  • Liaising with production managers, operators, and other relevant personnel as part of the review and update of MBRs and during production as required.
  • Responsible for the development, review, and update of MES Standard Operating.
  • Preparation and management of MBR change requests and associated change request forms (and other documentation) in a timely manner by liaising with customers, System Owner etc.
  • Accountable for adherence to established timelines and metrics for the change control and CAPA process.
  • Responsible for any applicable equipment integration design, configuration and testing to allow MBR interaction with shop floor equipment – OSI PI, Recipe Managers – Siemens, Rockwell, Kepware OPC Server.
  • Resolving interface errors and stock discrepancies between ERP/MES as required.
  • Liaising with MES core-team to troubleshoot and develop new ways of working.
Qualification and Experience
  • Bachelors’ in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering, or related life science engineering.
  • Minimum of 5+ years’ experience in operations/manufacturing environment.
  • MES experience with focus on workflow, S95 & S88 standards & integration from the control layer to ERP via MES.
  • Ability to interpret requirements and apply GMP and regulatory Knowledge as related to documentation.
  • Project Management.
  • Strong Technical writing for investigations, procedures and change controls.
  • Creation / Loading of Level 2 Recipes.
  • Strong PL/SQL programming experience in software development with Microsoft Visual Studio / Development tools; knowledge of web services, ASP and .net technologies.
  • Strong SQL experience with exposure to both Oracle & SQL Server databases along with Crystal Reports.
  • Experience in IT Infrastructure, Process Automation, Laboratory Systems and Enterprise Systems desirable
What SimoTech Can Offer
  • Role provides a high degree of autonomy to allow the successful candidate to reach their full potential
  • Develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment.
  • Opportunity to work with large corporate clients on exciting capital projects.
  • Flexible working hours and location.
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