Remote CSV Engineer – MedTech Validation & Compliance

BairesDev; Chile; Remote; CLP 88,063,000 - 117,417,000; Full time

Benefits offered by this job

100% remote work

Flexible hours

Global collaboration

Job summary

BairesDev is seeking a Computer System Validation (CSV) Engineer to ensure regulatory compliance for MedTech systems. You will author IQ/OQ/PQ protocols, perform validation, and manage data integrity across validated environments.

The role is 100% remote, offering flexible hours and opportunities to collaborate with a global Top 1% tech talent pool while maintaining rigorous documentation and compliance standards.

Qualifications

• 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.

Responsibilities

• Lead 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.

Skills

CSV validation experience

GxP validation

Data integrity assessments

Advanced English

Tools

Jira

Visio

Excel

Word

Adobe Acrobat

Job description

BairesDev is seeking a Computer System Validation (CSV) Engineer to ensure regulatory compliance for MedTech systems. You will author IQ/OQ/PQ protocols, perform validation, and manage data integrity across validated environments.

The role is 100% remote, offering flexible hours and opportunities to collaborate with a global Top 1% tech talent pool while maintaining rigorous documentation and compliance standards.