Descripción y detalle de las actividades
- 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.
Experiência y requisitos
**_
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 ISO***** and CFR 21 Part 11 and ****** and NOM241.
- Proficiency and knowledge in the Software validation process (SVA, UR, FR, TS, SVR).
- 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
Beneficios
- Beneficios de acuerdo a la LFT
- seguro de vida
- caja de ahorro
- comedor
- fondo de ahorro
- transporte
- uniforme
- gimnasio
- servicios médicos en planta
**Número de vacantes** 1
**Área** Calidad
**Contrato** Permanente
**Modalidad** Presencial
**Turno** Diurno
**Jornada** Tiempo Completo
**Estudios** Carrera con título competente
**Inglés**Hablado: Avanzado, Escrito: Avanzado
**Disponibilidad p.
viajar** No

📌 Sr Advanced Software Engineer (Tijuana)
🏢 Sistemas Médicos Alaris, S.A.De C.V.- Bd
📍 Tijuana