Experteer Overview In this MES Validation role, you will author and execute IQ, OQ, and PQ protocols for regulated FactoryTalk PharmaSuite configurations, ensuring traceability to requirements and test evidence. You will apply GAMP 5 and risk-based validation to define scope and maintain audit-ready documentation. Collaborating with configuration and quality teams, you will address deviations and support ALCOA+-driven data integrity across the system lifecycle. You will work within a cross-functional setting to connect MES with ERP, historians, and process control while upholding regulatory standards. This opportunity offers impact through shaping validated manufacturing platforms in a global, high-stakes lifeCompensaciones / Ventajas
- Author and execute IQ, OQ, and PQ protocols for FactoryTalk PharmaSuite configurations
- Maintain traceability between user,
functional, and design requirements and test evidence
- Apply GAMP 5 and risk-based validation approaches to define and document validation scope
- Collaborate with configuration and quality teams to investigate, remediate, and document deviations
- Support data integrity controls aligned to ALCOA+ across the system lifecycleResponsabilidades
- Bachelor's or Master's degree in Life Sciences, Engineering, Computer Science, or related field
- Previous experience in computer system validation, quality, or MES delivery in a regulated environment
- Proficiency in English (Spanish a plus)Requisitos principales
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