Job Description Summary

Job 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.

Software Role Technical Skills

• 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)

Technical Skills of the Packaging Role

• 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.

Technical Skills of the New Product Introduction Role

• 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.

Requirements:

• 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

"BD values ​​equity in the workplace without discrimination against any disability, class, ethnicity, age, religion, gender identity or sexual orientation."

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