IT Sofware Validation Engineer

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. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary.

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.

• 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.

• 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.

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