GMP MES Validation Specialist – Digital Batch

Simotechnology; Cork; On-site; EUR 70,000 - 98,000; Full time

Benefits offered by this job

Autonomy

Skills development

Major clients

Job summary

SimoTech is seeking an experienced MES Validation Engineer to support a paper-to-digital MES implementation in Cork. You will validate digital batch records, test interfaces with third-party systems, and verify workflows in a GMP environment.

The role involves developing and executing validation scripts, reviewing specs, and ensuring regulatory compliance, with opportunities to work across cross-functional teams in a growing digital manufacturing project.

Qualifications

• 3+ years’ experience in Computer System Validation (CSV) within a GMP-regulated manufacturing environment.
• 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.

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 (ERP, automation).
• Review and approve design specifications to ensure alignment with user requirements and GMP compliance.
• Document and manage test evidence, deviations, and validation deliverables per CSV and site standards.
• Support 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 MES developers, automation engineers, Quality, and IT to deliver a robust digital batch solution.

Skills

Attention to detail

Test scripting

Cross-functional collaboration

Education

Engineering / Computer Science / Life Sciences degree

Tools

Syncade MES testing

Job description

SimoTech is seeking an experienced MES Validation Engineer to support a paper-to-digital MES implementation in Cork. You will validate digital batch records, test interfaces with third-party systems, and verify workflows in a GMP environment.

The role involves developing and executing validation scripts, reviewing specs, and ensuring regulatory compliance, with opportunities to work across cross-functional teams in a growing digital manufacturing project.