Csv Engineer (Gxp Systems Engineer) (Baja California)

Role: CSV Engineer (Gx P Systems Engineer) Location: United States This opportunity is open only to candidates who are currently authorized to work in the United States. Role Overview: Support validation, delivery, and administration of Gx P laboratory and enterprise computerized systems. Work within the Digital Quality team to ensure system compliance, performance, and lifecycle management. Key Responsibilities: Manage lifecycle of lab systems (HIAC, FTIR, TOC, Bioanalyzers, Sequencers) and enterprise systems (Chromeleon, Logi Lab, Soft Max Pro). Translate business and technical requirements into digital lab system solutions. Lead and execute Computer System Validation (CSV) activities (URS, FRS, IQ/OQ/PQ, etc.). Author and maintain validation and compliance documentation. Act as system administrator for QC lab systems. Troubleshoot system issues and support incident resolution. Conduct periodic reviews, audit trail reviews, and user access reviews. Ensure GMP compliance and inspection readiness. Basic Qualifications: Bachelor's degree in STEM (or related field) 4+ years in c Gx P environment Experience with CSV documentation and lifecycle activities Familiarity with QMS, Document Management, Service Now Experience with KNEAT or similar SDLC tools Knowledge of change controls, deviations, and CAPA processes Preferred Skills: Experience with lab instruments (TOC, Bioanalyzers, Spectramax) Experience with systems like Chromeleon, Lab X Background in pharma/biotech or regulated industries Experience with data integration and lab connectivity Strong communication and ability to work cross-functionally. Postúlate en Kit Empleo: kitempleo.com.mx/empleo/5utuba