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.

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.

• →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.

KM09

Required Skills:

Optional Skills:

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. Please email accessibility@flex.com and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).