Job Summary: A professional who leads computerized systems validation activities, ensuring regulatory compliance and collaborating with interdisciplinary teams. Key Responsibilities: 1. Lead computerized systems validation activities under GAMP 5. 2. Ensure regulatory compliance with 21 CFR Part 11 / 820. 3. Collaborate with IT, Quality, and Manufacturing teams. Job Description and Detailed Responsibilities * 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, eDHR, 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 Experience and Requirements * \+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, eDHR, or ERP systems (preferred) Benefits * Benefits according to the Federal Labor Law (LFT) * Life insurance * Transportation * Uniform * Guaranteed profit sharing * Savings fund * On\-site medical services * Cafeteria **Number of Vacancies** 1 **Department** Quality **Employment Type** Permanent **Work Modality** On\-site **Shift** Day **Working Hours** Full\-time **Schedule*** Full\-time **Education** Bachelor\'s degree **English** Speaking: Intermediate, Writing: Advanced **Willingness to Travel** No