IT Sofware Validation Engineer

Flex; Aguascalientes; Presencial; MXN 600.000 - 900.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive Salary

Life & Medical Insurance

Christmas Bonus

Food Coupons

Saving Fund

KM09

Descripción de la vacante

Flex is seeking an IT Software Validation Engineer in Aguascalientes, Mexico, to validate software for regulated environments in medical device manufacturing. You will develop and execute CSV activities, create validation documentation, and ensure data integrity across systems.

You will collaborate with IT, Quality, Engineering, Manufacturing and Regulatory teams, support audits, and drive improvements in validation processes while maintaining compliance with applicable regulations.

Formación

• Bachelor's degree in Computer Science, IT or related discipline.
• Minimum 3 years in CSV/Software Validation within Medical Device/Life Sciences.
• Advanced English communication skills (written & verbal).
• Strong knowledge of FDA 21 CFR Part 11.
• Working knowledge of ISO 13485 and GAMP 5 methodologies.
• Experience validating software systems in regulated environments.
• Experience with SDLC, risk management and change control processes.
• Experience with ERP, MES, PLM, QMS, LIMS or similar systems.

Responsabilidades

• Develops and executes CSV activities for software in medical device manufacturing and quality systems.
• Creates, reviews, and approves validation docs: URS, FS, IQ/OQ/PQ, risk assessments, and reports.
• Validates new software systems, upgrades and customized solutions in regulated environments.
• Ensures compliance with FDA regulations including 21 CFR Part 11.
• Applies GAMP 5 principles and risk-based validation throughout lifecycle.
• Evaluates interfaces, data integrations and customizations for data integrity.
• Collaborates with IT, Quality, Engineering, Manufacturing and Regulatory teams.
• Supports audits and regulatory inspections with validation evidence.
• Participates in change management and assesses validation impact of modifications.
• Ensures ongoing compliance via periodic reviews and revalidation.
• Identifies opportunities for continuous improvement in validation processes.

Conocimientos

Advanced English

Analytical thinking

Regulatory compliance

Educación

Bachelor's degree in Computer Science or related field

Herramientas

ERP

MES

PLM

QMS

LIMS

Descripción del empleo

Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.

A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment.

Job Summary

Summary: To support our extraordinary teams who build great products and contribute to our growth, we're looking to add an IT Software Validation Engineer located in Aguascalientes , Mexico .

Responsibilities

• Develops and executes Computer System Validation (CSV) activities for software applications supporting medical device manufacturing and quality systems.
• Creates, reviews, and approves validation documentation including Validation Plans, User Requirements Specifications (URS), Functional Specifications (FS), Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Reports.
• Validates new software systems, upgrades, enhancements, and customized solutions used in regulated environments.
• Ensures compliance with FDA regulations, including FDA 21 CFR Part 11, and applicable quality system requirements.
• Applies GAMP 5 principles and risk-based approaches throughout the software validation lifecycle.
• Evaluates and validates process interfaces, data integrations, and system customizations to ensure data integrity and system reliability.
• Collaborates with IT, Quality, Engineering, Manufacturing, and Regulatory Affairs teams to define validation requirements.
• Supports audits and regulatory inspections by providing validation evidence and documentation.
• Participates in change management activities and assesses validation impacts resulting from system modifications.
• Ensures validated systems remain compliant throughout their lifecycle through periodic reviews and revalidation activities.
• Identifies and implements continuous improvement opportunities related to validation processes and regulatory compliance.

Qualifications

• Bachelor's degree in Computer Science, Information Technology, Software Engineering, Biomedical Engineering, or related discipline.
• Minimum 3 years of experience in Computer System Validation (CSV), Software Validation, or IT Validation within Medical Device, Pharmaceutical, or Life Sciences industries.
• Advanced English communication skills, both written and verbal.
• Strong knowledge of FDA regulations, including 21 CFR Part 11.
• Working knowledge of ISO 13485 and GAMP 5 methodologies.
• Experience validating software systems used in regulated environments.
• Experience with software implementation, customization, and process interfaces.
• Experience developing and maintaining medical validation documentation.
• Strong understanding of Software Development Life Cycle (SDLC), risk management, and change control processes.
• Experience with systems such as ERP, MES, PLM, QMS, LIMS, or other regulated applications is preferred.
• Strong analytical, troubleshooting, and problem-solving skills.

The experience we're looking to add to our team

• 3+ years of experience performing Computer System Validation (CSV).
• Experience validating software used in medical device environments.
• Knowledge of FDA, ISO 13485, and GAMP 5 requirements.
• Experience with process interfaces, system integrations, and data integrity controls.
• Experience creating and maintaining validation deliverables and compliance documentation.
• Advanced English proficiency.

What you'll receive for the great work you provide

• Competitive Salary.
• Life & Medical Insurance.
• Christmas Bonus.
• Food Coupons.
• Saving Fund.
• KM09

Job Category: IT

Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process.