At BairesDev®, we've been leading the way in technology projects for over 15 years. We deliver cutting-edge solutions to giants like Google and the most innovative startups in Silicon Valley.

Our diverse 4,000+ team, composed of the world's Top 1% of tech talent, works remotely on roles that drive significant impact worldwide.

When you apply for this position, you're taking the first step in a process that goes beyond the ordinary. We aim to align your passions and skills with our vacancies, setting you on a path to exceptional career development and success.

Computer System Validation (CSV) Engineer at BairesDev

In this role, you'll ensure that computerized systems supporting medical device operations are validated and compliant with industry regulations. This is a hands-on position where your rigor and attention to detail directly protect product quality and patient safety. This is your opportunity to work at the intersection of technology and regulatory compliance in the MedTech space.

What You'll Do

• Lead computer system validation (CSV) activities for GxP computerized systems.




• Author and execute IQ/OQ/PQ validation protocols.
• Manage test execution and defect tracking through Jira.
• Conduct data integrity assessments across validated systems.
• Support system upgrades, migrations, and change control processes.
• Document validation evidence in line with regulatory standards.

What We Are Looking For

• 5+ years of experience in computer system validation (CSV).
• Background in GxP computerized systems validation.
• Familiarity with MedTech or medical device environments.
• Hands-on experience authoring IQ/OQ/PQ validation protocols.
• Proficiency in Jira for test management and defect tracking.
• Experience conducting data integrity assessments.
• Advanced proficiency in English.

Nice To Have

• Experience supporting system upgrades, migrations, and change control.
• Background in vendor selection and qualification.
• Knowledge of 21 CFR Part 11, EU

📌 Computer System Validation (México)
🏢 BairesDev
📍 México