MES CSV Validation Engineer - Digital Batch (Syncade)

Simotechnology

Limerick

Hybrid

EUR 65,000 - 90,000

Full time

14 days+

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Benefits offered by this job

Competitive salary

Benefits

Educational support

Job summary

SimoTech in Co. Limerick is seeking an experienced MES Validation Engineer to support a digital MES implementation project. You will deliver Digital Batch Records (EBRs/MBRs) on Syncade MES, perform testing, validation, and interface verification with third-party systems in a GMP environment.

The role collaborates with MES developers, automation, Quality and IT, validating workflows, recipes, and system integrations, contributing to regulatory compliance and a robust digital batch solution.

Qualifications

Degree in Engineering, Computer Science, Life Sciences, or related discipline.
3+ years’ experience in Computer System Validation (CSV) within a GMP-regulated manufacturing environment.
Strong hands-on experience with Syncade MES testing and validation, including EBR development and workflow approval.
Solid knowledge of GxP and GAMP 5 guidelines for MES systems and integrations.
Proven expertise in writing and executing test scripts, managing deviations, and compiling validation reports.
Familiarity with interface testing between MES and external systems (ERP, automation, or historians).
Excellent attention to detail and strong documentation skills.
Ability to work effectively in a hybrid setting and engage with multiple project stakeholders.

Responsibilities

Develop and execute test scripts and validation protocols for MES recipes (EBRs/MBRs), workflows, and system configurations in Syncade.
Perform interface testing between Syncade MES and integrated third-party systems (e.g., ERP).
Review and approve design specifications to ensure alignment with user requirements and GMP compliance.
Document and manage test evidence, deviations, and validation deliverables in accordance with CSV and site quality standards.
Support User Acceptance Testing (UAT) and participate in issue resolution during qualification and deployment.
Ensure compliance with GMP, GAMP 5, and regulatory requirements for MES validation activities.
Collaborate with cross-functional teams including MES developers, automation engineers, Quality, and IT to deliver a robust and compliant digital batch solution.