MES Validation Engineer (CSV) – GMP & Syncade Expert

SimoTech

Limerick

Hybrid

EUR 65,000 - 90,000

Full time

14 days+

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Benefits offered by this job

Autonomy

Skill development

Large corporate projects

Job summary

SimoTech in Ireland is seeking an experienced MES Validation Engineer to support a digital MES implementation project based in Co. Limerick.

The role involves delivering Digital Batch Records (EBRs/MBRs) on MES, including testing, validation, and interface verification with third-party systems in a regulated GMP environment. The ideal candidate will work within a cross-functional team to verify workflows, recipes, and system integrations, combining validation expertise with exposure to advanced

Qualifications

Degree in Engineering, Computer Science, Life Sciences, or related discipline.
1+ year of hands-on CSV testing in GMP environments is preferred.
Experience with MES validation and CSV documentation is required.
Familiarity with GxP and GAMP 5 guidelines for MES systems.

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., automation platforms, 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 phases.
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.