Sr Validation Software Engineer

Sistemas Médicos Alaris, S.A.de C.V.- BD; Tijuana; Presencial; MXN 732,000 - 1,100,000; Jornada completa

Descripción de la vacante

A medical devices company in Tijuana is looking for a Senior Advanced Software Engineer to lead software validation and quality assurance efforts. The ideal candidate will have a Bachelor's degree in a related field and 4 to 5 years of relevant experience. Strong English communication skills and knowledge of quality control systems are essential. This role involves ensuring compliance with regulatory guidelines and participating in new product introductions.

Formación

• 4 to 5 years of experience in a similar role.
• Advanced English communication skills.

Responsabilidades

• Ensure validations are conducted in accordance with the master validation plan.
• Lead software development and improvement projects on site.
• Conduct annual revalidation evaluations of the manufacturing site.
• Review and approve validation protocols.
• Participate in the introduction of new products.

Conocimientos

Knowledge of Quality Control

Knowledge of regulated Quality Systems

Proficiency in Software validation process

Mastery of GAMP 5

Experience in Computer Systems Validation

Risk Analysis Management

Knowledge of data integrity validation

Knowledge of software tools (labelview, codesoft, loftware)

Educación

Bachelor’s degree in Industrial, Chemical or Related Engineering

Descripción del empleo

Responsibilities

• 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