Computer System Validation (CSV) Engineer – Remote

About the role

As a Computer System Validation (CSV) Engineer at BairesDev, you will ensure that computerized systems supporting medical device operations are validated and compliant with industry regulations. This hands‑on role directly protects product quality and patient safety while working at the intersection of technology and regulatory compliance in the MedTech space.

Key responsibilities

• Lead CSV activities for GxP computerized systems, authoring and executing IQ, OQ, and PQ validation protocols.
• Manage test execution and defect tracking using 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, preferably in a MedTech or medical device environment.
• 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.

Required skills

• Jira
• Microsoft Visio
• Microsoft Excel
• Microsoft Word
• Adobe Acrobat

What we offer

• 100% remote work from anywhere.
• Excellent compensation in USD or local currency.
• Hardware and software setup for home office.
• Flexible hours – create your own schedule.
• Paid parental leave, vacations, and national holidays.
• Innovative, multicultural environment with global top‑talent collaboration.
• Mentorship, promotions, skill development, and diverse growth opportunities.