Computer System Validation (CSV) Engineer - Remote

About the role

BairesDev is hiring a Computer System Validation (CSV) Engineer to work remotely. The role ensures that computerized systems supporting medical device operations are validated and compliant with industry regulations, protecting product quality and patient safety. It sits at the intersection of technology and regulatory compliance in the MedTech space.

Key responsibilities

• 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.

Required profile

• 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.
• Advanced proficiency in English.

Required skills

• Proficiency in Jira for test management and defect tracking.
• Experience conducting data integrity assessments.
• Nice to have: knowledge of 21 CFR Part 11, EU GMP Annex 11 and GAMP 5; experience with system upgrades, migrations and change control; vendor selection and qualification background.
• Nice to have: Microsoft Office (Visio, Excel, Word) and Adobe Acrobat.

What we offer

• 100% remote work from anywhere.
• Excellent compensation in USD or your local currency if preferred.
• Hardware and software setup provided for working from home.
• Flexible hours and the ability to set your own schedule.
• Paid parental leave, vacations and national holidays.
• Mentorship, promotions, skill development and a multicultural environment.