Description

• Responsible for ensuring that validations are carried out in the applicable processes in accordance with the guidelines established in the validation master plan.
• Responsible for ensuring that the validations scheduled annually are carried out and maintained in accordance with the procedures of the quality system.
• Provide on-site leadership for software development and improvement projects.
• Responsible for providing technical knowledge during planning, validation, research or audit activities relevant to his/her area of knowledge.
• Responsible for conducting annual revalidation evaluations of the manufacturing site.
• Determines revalidation needs based on applicable regulatory changes.
• Coordinate validations of your knowledge area for new processes/equipment/software in the quality area.
• Conducts improvement projects in relation to their area of knowledge.
• He serves as the ultimate guide and authority in the role of Sr. Advanced Software Engineer of the site.
• Responsible for establishing and maintaining a Master Plan of Software Validations including its static and dynamic part in adherence to the site quality system and applicable regulations.
• Responsible for establishing and maintaining a software validation procedure in adherence to the quality system.
• Responsible for reviewing and approving validation protocols that include any software, routine, algorithm, Excel sheet or any other applicable to automated operations as applicable.
• Responsible for providing guidance in acquisition, transfer or implementation of software applicable to the operation.
• You will need to participate in the introduction of new products by interacting with the New Product Introduction Validation Engineer as the expert in the area of software validation.

• Knowledge of Quality Control such as Capacity Indexes, Sampling Plans, FMEA, Process Control, Risk Mitigation, Trend Analysis, Process Improvement, LAYERING, Customer Complaints, and Non-Conforming Material Handling.
• Extensive knowledge in regulated Quality Systems for the manufacture of Medical Devices such as ISO13485 and CFR 21 Part 11 and 820.70 and NOM241.
• Proficiency and knowledge in the Software validation process (SVA, UR, FR, TS, SVR).
• Mastery, knowledge and application of GAMP 5 (Good Automated Manufacturing Practices).
• Proficiency in Computer Systems Validation (Certification/Training)
• Experience validating data integrity using GAMP 5
• Risk Analysis Management
• Knowledge of the following softwares is a plus (labelview, codesoft, loftware)

• Extensive knowledge in thermoforming, sealing and labeling processes.
• Knowledge of labelview, codesoft, loftware software
• Extensive knowledge in Validation Plan, IQ, DOE, OQ, PQ, TMV (Continuous Variables/Attributes - Destructive/Non-Destructive) relevant to the thermoforming, sealing and labeling process.
• Basic knowledge of materials used for packaging such as Tyvek and Films.

• Mitigation, Trend Analysis, Process Improvement, LAYERING, Customer Complaints, and Non-Conforming Material Handling.
• Extensive knowledge in the design process and design transfer.
• Basic knowledge of using Solid Works.

• Bachelor's degree in Industrial, Chemical or Related Engineering ted field
• 4 to 5 years of Experience in similar roll.
• Advanced English communication skills
• Conocimiento en el proceso de control, órdenes y requisiciones de cambios a los documentos del sistema de calidad.
• Conocimiento de Control de Calidad tales como Índices de Capacidad, Planes de Muestreo, FMEA, Control de Proceso, Mitigación de Riesgos, Análisis de Tendencias, Mejora de Procesos, CAPAS, Quejas de Clientes y Manejo de Material no Conforme
• Conocimiento amplio en Sistemas de Calidad regulados para la manufactura de Dispositivos Médicos tales como ISO13485 y CFR 21 Parte 11 y 820.70
• Dominio en el proceso de validación de Software (SVA, UR, FR, TS, SVR)
• Conocimiento básico de programación