IS/Automation Manufacturing Information Systems Architect

SimoTech requires an experienced IS/Automation Manufacturing Information Systems Architect, for a large-scale BioTech project in Dublin. Candidates must have at least 5+ years’ experience working within the Pharma/BioTech sector. As a member of the Operations IS Automation team, the role will support complex and challenging system automation initiatives with strong knowledge in systems such as SCADA, MES and PLC.

Key Responsibilities
  • Responsible for the delivery of new and updated integration functionalities for Manufacturing Information Systems for use in production.
  • Responsible for oversight on alignment of Manufacturing Information Systems with Global Operating Specifications.
  • Responsible for the development, configuration and testing for integration components of Master Batch Records (MBRs) from initial to final design.
  • Responsible for leading integration development design reviews including liaising with Automation, Operations, Process Development, Validation and Quality functions.
  • Responsible for any applicable equipment integration design, configuration and testing to allow MBR interaction with shop floor equipment and lab equipment for in-process testing.
  • Responsible for liaising with Plant Support, System Owner and Operations teams regarding documentation changes in an effective and timely manner.
  • Responsible for support and updates to Recipe Control system – an in-house online recipe management system.
  • Responsible for the MBR design oversight, support and ongoing development of the MES system.
  • Responsible for training of Electronic Batch Record (EBR) designers and end-users on MES integration activities and development of job aids.
  • Responsible for support and to assist in fast Manufacturing Execution System (MES) issue resolution where required and as directed by Operations leadership.
  • Responsible for the development, review and update MES Standard Operating Procedures and Design Specifications.
  • Support continuous area improvement, by proactively identifying and supporting implementation of improvement opportunities for MES integration removing paper from the execution and review process to reduce cycle times.
  • Support implementation of process changes.
  • Responsible to perform all activities in compliance with site safety standards and site safety procedures.
Qualifications
  • Working knowledge of drug product manufacturing and packaging in pharmaceutical/biotech industries or aseptic processing.
  • Knowledge of regulation requirements (including cGMP, 21CFR Part11).
  • Knowledge of Quality Systems (e.g. CCMS, EDMQ, NC/CAPA).
  • Knowledge of validation processes and understanding of validation protocol generation requirements.
  • Knowledge of computer systems applicable to responsibilities (e.g. MES, ERP, SCADA, PLC, Historian).
  • Practical knowledge in continuous improvement tools and methodologies.
  • MES experience with focus on workflow, S95 & S88 standards and integration from the control layer to MES in pharma & bio-pharma industries.
  • Strong capabilities in S95 level 2 and level 3 systems and their integration.
  • Strong working knowledge of OLE for Process Control.
  • Experience of Supervisory Control and Data Acquisition (SCADA), Process Control Systems (PCS), Recipe Managers – Siemens, Rockwell, Kepware OPC Server, OSI Pi, RT Reports, OSI PI Asset Framework, Laboratory benchtop equipment, Learning Management Systems.
  • Strong exposure to MES technologies, including automated data collection, historian applications (OSI PI), visualization, quality and efficiency in manufacturing.
  • MES experience in implementing stable and scalable solutions for.
    • Continuous Data Retrieval from Level 2 and Level 3 systems.
    • Creation / Loading of Level 2 Recipes.
    • Retrieval of Alarms and Events (Batch Context Information) into MES for Annotation, Review and Trending.
  • 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.
  • Strong attention to details, including the ability to proof read documents and to accurately translate customers’ requirements into meaningful end-user instructions consistently.
  • Excellent organizational and communication (verbal and written) skills at all levels of the organization.
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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