MES MBR Engineer

Location: Dublin, Ireland

Job Description:

We are seeking a skilled MES MBR Engineer to join our team in Dublin. The ideal candidate will be responsible for the development, configuration, and testing of integration components for Master Batch Records (MBRs) from initial to final design. This role involves leading integration development design reviews and collaborating with various departments including Automation, Operations, Process Development, Validation, and Quality.

Key Responsibilities:

• Develop, configure, and test integration components of MBRs from initial to final design.
• Lead integration development design reviews, liaising with Automation, Operations, Process Development, Validation, and Quality functions.
• Design, configure, and test equipment integration to enable MBR interaction with shop floor and lab equipment for in-process testing.
• Liaise with Plant Support, System Owner, and Operations teams regarding documentation changes effectively and timely.
• Provide support and updates to the Recipe Control system – an in-house online recipe management system.
• Oversee MBR design, support, and ongoing development of the client site MES system.
• Train Electronic Batch Record (EBR) designers and end-users on MES integration activities and develop job aids.
• Support and assist in rapid MES issue resolution as directed by Operations leadership.
• Develop, review, and update MES Standard Operating Procedures and Design Specifications.
• Contribute to extending our MES solution and developing project and technical skillsets in collaboration with our team and vendor consultants.

Qualifications:

• Experience in drug product manufacturing and packaging in pharmaceutical/biotech industries or aseptic processing.
• Knowledge of regulatory requirements (cGMP, 21CFR Part11) and Quality Systems (e.g., CCMS, EDMQ, NC/CAPA).
• Understanding of validation processes and protocol generation.
• Familiarity with MES, ERP, SCADA, PLC, and Historian systems.
• Practical knowledge in continuous improvement tools and methodologies.
• MES experience with a focus on workflow, S95 & S88 standards, and integration from the control layer to MES.
• Strong capabilities in S95 level 2 and level 3 systems and their integration.
• Hands-on exposure to Korber MSI, OSI PI AF/EF, and Kepware OPC interfaces.
• Experience with SCADA, PCS, Recipe Managers, and Learning Management Systems.
• Strong exposure to MES technologies, including automated data collection and historian applications (OSI PI).
• Experience in implementing MES solutions for data retrieval, recipe creation/loading, and alarm/event retrieval.
• Proficiency in PL/SQL programming, web services, ASP, .NET technologies, and SQL (Oracle & SQL Server).
• Excellent attention to detail and organizational skills.
• Strong communication skills at all levels of the organization