Job Description and Responsibilities * Execute and track IQ, OQ, and PQ activities. * Develop and review validation protocols, reports, and documentation. * Coordinate validation of automated equipment, software, and computerized systems. * Participate in risk assessments and deviation/CAPA management. * Support internal, external, and regulatory audits. * Ensure compliance with 21 CFR Part 11, GDP, and internal procedures. * Collaborate with Engineering, Quality, Manufacturing, and IT departments. Experience and Requirements * Completed engineering degree (Industrial, Biomedical, Mechatronics, Electronics, or related field). * Experience in medical device, pharmaceutical, or other regulated industries. * Knowledge of CSV/CSA, GAMP 5, IQ/OQ/PQ, and FDA 21 CFR Part 11\. * Intermediate-to-advanced English proficiency. * Ability to produce technical documentation and work in multidisciplinary teams. * Experience with MES/eDHR, automation, or manufacturing systems. * Knowledge of software validation and data integrity. Benefits * Benefits as per Mexican Federal Labor Law (LFT) * Life Insurance * Uniform * Savings Fund * Guaranteed Profit Sharing * On-site Medical Services * Cafeteria * Gym **Number of Vacancies** 1 **Department** Engineering **Employment Type** Permanent **Work Modality** On-site **Shift** Day Shift **Working Hours** Full-time **Education Required** Bachelor's degree with professional title **English Proficiency** Spoken: Intermediate, Written: Intermediate **Willingness to Travel** No
Juan García
Indeed · HR
Juan García
Indeed · HR
