Location: Dublin 15 | Permanent Position | API Manufacturing Environment
Overview
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.
Key Responsibilities
PAS-X Ownership & Governance
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.
Systems Integration
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.
Testing, Validation & Compliance
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.
Operational Support
Act as escalation point for PAS-X system issues.
Monitor system performance and drive continuous improvement.
Support production troubleshooting and deviation resolution.
Training & Capability Development
Mentor manufacturing users and super-users.
Drive adoption of digital manufacturing practices.
Contribute to the development of long-term MES capability on site.
Project Delivery
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.
Why Apply?
Join a highly digital, modern API manufacturing environment.
Play a key role in shaping MES capability and digital batch execution.
Influence system design, governance, and site-wide digital strategy.
Work cross-functionally at the centre of manufacturing, quality, and automation
#J-18808-Ljbffr