Software validation engineer (csv) (tijuana)

Descripción y detalle de las actividades Execute and lead computerized systems validation activities under GAMP 5 Develop and review validation documentation: URS, FS, DS, IQ, OQ, PQ Ensure regulatory compliance with 21 CFR Part 11 / 820 Coordinate functional, integration, and system validation testing (MES, e DHR, ERP) Manage deviations, CAPAs, and change control related to validated systems Collaborate with IT, Quality, and Manufacturing teams to implement digital solutions Participate in internal and external audits (FDA, ISO) Perform risk assessments and define risk-based validation strategies Support system release and maintain validated state Experiencia y requisitos +3 years of experience in Computerized Systems Validation (CSV) Experience in the medical device industry or other highly regulated environments Knowledge of FDA regulations and ISO 13485 Professional English proficiency Experience with digital tools such as MES, e DHR, or ERP systems (preferred) Beneficios Beneficio...