Computer System Validation (CSV) Engineer - Remote Work | REF#305381

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

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 GMP Annex 11, and GAMP 5 guidelines.
• Proficiency in Microsoft Office (Visio, Excel, Word) and Adobe Acrobat.

How we do make your work (and your life) easier:

• 100% remote work (from anywhere).
• Excellent compensation in USD or your local currency if preferred
• Hardware and software setup for you to work from home.
• Flexible hours: create your own schedule.
• Paid parental leaves, vacations, and national holidays.
• Innovative and multicultural work environment: collaborate and learn from the global Top 1% of talent.
• Supportive environment with mentorship, promotions, skill development, and diverse growth opportunities.

Join a global team where your unique talents can truly thrive and make a significant impact!