MES Engineer

Location: Dublin 15 | Permanent Position | API Manufacturing Environment

An exciting opportunity has arisen for an experienced Senior PAS-X (MES) Engineer to join a highly digitalised small-molecule API manufacturing facility in Dublin.

This role sits within a growing Digital / OT function and will act as the site’s primary PAS-X Subject Matter Expert, responsible for the design, configuration, deployment, and continuous optimisation of the Körber PAS-X Manufacturing Execution System (MES).

You will operate within a sophisticated, data-driven production environment, collaborating closely with Manufacturing, Quality, Automation, Engineering, IT, and external system partners to deliver robust electronic batch execution and seamless system integration.

This position plays a critical role in enabling right-first-time manufacturing, digital tech transfer, and inspection-ready operations.

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• Act as technical authority for PAS-X architecture and configuration standards.
  
• Define and maintain lifecycle governance and site configuration strategy.
  
• Develop modular eMBR templates, recipe structures, equipment models, alias/state management, and metadata frameworks.
  
• Lead the design and build of electronic Master Batch Records aligned to ISA S88/S95.
  
• Configure IPCs, sampling plans, data capture workflows, and electronic signatures to ensure GMP compliance.
  
• Optimise batch workflows to improve cycle time and right-first-time performance.
  

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• Drive integrations between PAS-X and core enterprise / automation systems (ERP, DCS, Historian, LIMS, and Quality platforms).
  
• Ensure master data alignment, data integrity, and full traceability across systems.
  
• Support digital tech transfer and data handover initiatives.
  

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• Lead UAT planning and execution.
  
• Author and review validation documentation in line with GAMP 5.
  
• Maintain system validated state via structured change control and defect management.
  
• Own documentation standards and governance processes.
  

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• Act as escalation point for PAS-X system issues.
  
• Monitor system performance and drive continuous improvement.
  
• Support production troubleshooting and deviation resolution.
  

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• Mentor manufacturing users and super-users.
  
• Drive adoption of digital manufacturing practices.
  
• Contribute to the development of long-term MES capability on site.
  

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• Lead PAS-X workstreams for NPIs, upgrades, template governance, and digital initiatives.
  
• Coordinate activities with external system vendors and integration partners.
  
• Strong hands-on experience with Körber PAS-X, including PCS administration, eMBR build, equipment modelling, and deployment.
  
• Proven background in small-molecule API manufacturing within a cGMP environment.
  
• Experience integrating MES with ERP, DCS, Historian, and LIMS systems.
  
• Strong working knowledge of ISA S88 and S95.
  
• Demonstrated CSV expertise including URS/FRS/DS authoring, test scripting, and UAT execution.
  
• Ability to translate business and manufacturing requirements into scalable MES solutions.
  
• Excellent stakeholder management and cross-functional collaboration skills.
  
• PAS-X upgrades and multi-site template governance.
  
• Modular recipe library design.
  
• Digital tech transfer and analytics enablement.
  
• Lean or Agile delivery environments.
  
• Experience authoring GMP documentation and training materials.
  

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• Join a highly digital, modern API manufacturing environment.
  
• Play a key role in shaping MES capability and digital batch execution. xcfaprz
  
• Influence system design, governance, and site-wide digital strategy.
  
• Work cross-functionally at the centre of manufacturing, quality, and automation