MES Validation Specialist (Electronic Batch Record)

About the job

We are seeking an MES Validation Engineer to support validation activities for Electronic Batch Record (EBR) systems within a GMP-regulated manufacturing environment. The role involves reviewing validation documentation, supporting MES testing activities, assessing system and data mapping requirements, and ensuring compliance with GMP, GDP, and data integrity standards.

Your missions

• Support MES validation activities for Electronic Batch Record systems
• Review validation packages, including protocols, test scripts, reports, and supporting documents
• Review and assess URS, functional specifications, data mapping, and validation documentation
• Support execution or review of MES validation testing, where required
• Ensure validation activities comply with GMP, GDP, and data integrity requirements
• Collaborate closely with Manufacturing, Quality, Validation, Automation, and IT teams
• Identify documentation gaps and support remediation or follow-up actions
• Ensure Electronic Batch Record workflows are aligned with shopfloor manufacturing operations
• Support audit readiness by maintaining clear and complete validation documentation

Your profile

• Bachelor’s degree in Engineering, Life Sciences, Information Technology, or related field.
• 5-7 years of experience in MES validation within pharmaceutical, biotech, or GMP-regulated manufacturing environments.
• Prior experience with Electronic Batch Record (EBR) validation activities.
• Familiarity with MES validation lifecycle activities, including URS review, data mapping, validation testing, and documentation review.
• Ability to review and execute MES validation packages and related GMP documentation.
• Strong understanding of GMP, GDP, and data integrity principles.
• Good understanding of manufacturing processes and shopfloor operations within regulated environments.
• Ability to collaborate effectively with QA, Manufacturing, Validation, Automation, and IT stakeholders.
• Strong attention to detail, structured working approach, and ability to review technical documentation accurately.
• Fluent in English, both written and spoken.

What we offer

• An international community, bringing together 110+ different nationalities
• An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
• A robust training system with our internal Academy and 250+ available modules
• A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)
• At Mantu, sustainability is part of everything we do. You’ll have the opportunity to turn your ideas into action and make a tangible impact. Every day, our teams bring our ESG commitments to life, from reducing our footprint to driving positive change within our communities. Through our WeCare Together program, you’ll be empowered to design and lead projects that create real social or environmental impact, with the company’s full support.