Remote CSV Engineer - MedTech Validation & Compliance

BairesDev; United States; Remote; USD 90,000 - 135,000; Full time

Benefits offered by this job

100% remote work

Competitive USD salary or local option

Flexible hours

Home office setup provided

Parental leave and vacations

Global mentorship and growth

Job summary

BairesDev is seeking a Computer System Validation (CSV) Engineer to ensure medtech systems meet regulatory standards. This hands-on role protects product quality and patient safety through rigorous validation.

You’ll collaborate with cross-functional teams, author IQ/OQ/PQ protocols, manage Jira-based testing, and help drive upgrades and change control in a fully remote, global environment. We value precision, compliance discipline, and clear documentation across validated systems.

Qualifications

• 5+ years of CSV experience in GxP environments.
• Experience validating electronic records and data integrity.
• Familiarity with 21 CFR Part 11, EU GMP Annex 11, and GAMP 5.
• Strong stakeholder communication and regulatory compliance focus.
• Advanced English proficiency.

Responsibilities

• Lead CSV activities for GxP systems.
• Author and execute IQ/OQ/PQ validation protocols.
• Manage test execution and defect tracking in Jira.
• Conduct data integrity assessments across validated systems.
• Support system upgrades, migrations, and change control.
• Document validation evidence per regulatory standards.

Skills

CSV validation

GxP validation

Jira

IQ/OQ/PQ protocols

Data integrity

Regulatory compliance

English proficiency

Tools

Jira

Microsoft Office

Job description

BairesDev is seeking a Computer System Validation (CSV) Engineer to ensure medtech systems meet regulatory standards. This hands-on role protects product quality and patient safety through rigorous validation.

You’ll collaborate with cross-functional teams, author IQ/OQ/PQ protocols, manage Jira-based testing, and help drive upgrades and change control in a fully remote, global environment. We value precision, compliance discipline, and clear documentation across validated systems.