MES Validation Specialist

We are seeking an MES Validation Specialist in Galway to lead support for MES and GxP platforms. You will ensure system reliability and regulatory compliance through rapid troubleshooting and continuous validation activities.

Key Responsibilities:

• Provide first-line troubleshooting and root cause analysis for MES and GxP systems to minimize manufacturing downtime.
• Draft and execute validation protocols (IQ/OQ/PQ) ensuring all systems meet regulatory and site-specific requirements.
• Manage Change Controls, Deviations, and CAPAs within the Quality Management System (QMS) to maintain a validated state.
• Support system enhancements, configuration changes, and periodic system reviews to drive operational efficiency.
• Work closely with IT, Engineering, and Quality teams to ensure audit readiness and provide documentation during inspections.

Requirements:

• Bachelor's degree in Computer Science, Engineering, Information Technology, or a related technical field.
• Extensive hands-on experience with MES platforms (Rockwell PharmaSuite experience is highly advantageous)
• Strong understanding of GxP regulations, Good Documentation Practices (GDP), and Good Testing Practices (GTP).
• Excellent teamwork skills with a focus on clear, compliant technical documentation.