Job Description:We are seeking an experienced Validation Support Engineer to lead validation activities for Beckhoff Twin CAT PLC-controlled systems in a 24/7 GMP-regulated manufacturing environment.The role focuses on ensuring compliance with FDA regulations (21 CFR Part 11, 210, 211, 820), GAMP5 methodologies, and internal quality standards.Responsibilities:Develop/update Validation Plans (VP) and Master Validation Plans (MVP).Lead GxP risk assessments for system changes.Author and execute IQ/OQ/PQ protocols.Maintain Requirements Traceability Matrices (RTM).Investigate and manage deviations; support RCA and CAPA processes.Create Validation Summary Reports (VSR).Ensure full compliance with regulatory and quality standards.Requirements:5–8 years of experience in Computer System Validation (CSV).Strong knowledge of FDA regulations and GAMP5.Hands-on experience validating PLC-controlled systems.Beckhoff Twin CAT PLC and Ether CAT hardware experience is a strong plus.
