Vacancy Description
We are looking for an experienced Manufacturing Systems Test Engineer to support validation and testing activities for Manufacturing Execution Systems (MES)
Required Qualification
- s6–10 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
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