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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 life
Compensaciones / Incentivos
• 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 xqbhyrx data integrity controls aligned to ALCOA+ across the system lifecycle
Responsabilidades
• 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)