Manufacturing Systems Test Engineer

We are looking for an experienced Manufacturing Systems Test Engineer to support validation and testing activities for Manufacturing Execution Systems (MES)

Required Qualification

• s610 years of experience in Computer System Validation (CSV) within a GxP-regulated environment
• .Hands-on experience validating MES, EBR, Data Historian, or IT/OT manufacturing systems
• .Strong knowledge of
• :GAMP
• 521 CFR Part 1
• 1EU Annex 1
• 1cGM
• PALCOA+ Data Integrit
• yExperience authoring and executing IQ/OQ/PQ/UAT documentation
• .Experience with change control, deviation management, CAPA, and risk-based validation
• .Excellent technical documentation and stakeholder communication skills