Quality Engineer
Core
Supporting and reviewing MES validation activities, ensuring data integrity, and maintaining documentation compliance for manufacturing processes.
Role type
Quality Engineer (MES Validation)
Builds
Validated Electronic Batch Records (eBR) and compliant manufacturing systems
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
MES validation, CSV lifecycle management, GMP compliance, data integrity assurance, GAMP5 knowledge, 21 CFR Part 11 compliance, Annex 11 compliance, data mapping evaluation, cross-functional collaboration
Preferred skills
Experience with ERP and automation systems integration
Technologies
MES, ERP, automation systems
Responsibilities
Support implementation, validation, and ongoing management of Electronic Batch Records (eBR) within MES platforms; Review and verify batch record configuration, workflows, and execution; Ensure accuracy, completeness, and compliance of electronic batch records with GMP and data integrity requirements; Support execution or oversight of system validation activities; Evaluate data mapping between systems to ensure correct data flow and integrity
Seniority
Mid-Senior, hands-on IC
