Computer System Validation (CSV) Engineer - Remote Work | REF#305382

BairesDev; Chile; Remoto; CLP 88.063.000 - 127.202.000; Tempo pieno

Vantaggi offerti da questo lavoro

Remote work (100%)

USD or local currency compensation

Hardware provided

Flexible hours

Paid parental leave

Holidays and growth opportunities

Global, multicultural team mentorship

Descrizione del lavoro

BairesDev in Chile is seeking a seasoned Computer System Validation (CSV) Engineer to ensure that regulated software and GxP systems meet industry standards. This hands-on role focuses on validating computerized systems, maintaining compliance, and safeguarding patient safety in MedTech environments.

You will author IQ/OQ/PQ protocols, manage test execution in Jira, perform data integrity assessments, and support system upgrades while working 100% remotely with flexible schedules and a global,

Competenze

• 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.

Mansioni

• 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.

Conoscenze

CSV validation

GxP compliance

MedTech environments

IQ/OQ/PQ protocols

Jira test management

Data integrity assessments

English proficiency

Regulatory documentation

Strumenti

Jira

Visio

Excel

Word

Adobe Acrobat

Descrizione del lavoro

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!