21137 - Computer System Validation (CSV) Engineer

Qualitest is the world’s leading AI-powered Quality Engineering company.

With 8,000+ experts worldwide and 1,500 in Israel, we partner with top global brands to deliver smarter, faster, and more reliable technology solutions.

For the fifth year in a row, Qualitest has been recognized as one of Israel’s Top 100 Best Places to Work, reflecting our commitment to a stable, supportive, and growth-oriented workplace.

We’re Hiring: QA Engineer – Computer System Validation (CSV) Engineer based in Netanya to support validation activities for computerized systems used in regulated Life Sciences environments.

Responsibilities

• Ensure computer systems comply with applicable regulations and standards throughout their full lifecycle, including implementation, upgrades, and ongoing operation.
• Plan, execute, and maintain Computer System Validation (CSV) activities in accordance with industry best practices.
• Execute CSV activities in compliance with regulatory requirements such as GxP, FDA 21 CFR Part 11, and EU GMP Annex 11.
• Participate in system lifecycle activities including implementation, upgrades, migrations, and system decommissioning.
• Prepare, review, and maintain validation documentation, including implementation, upgrades, migrations, and decommissioning.
• Prepare and review validation documentation including:Validation PlansUser Requirements Specifications (URS)Risk Assessments (e.g., GAMP 5 based).
• Support risk-based validation approaches and leverage supplier documentation when applicable.
• Perform and support testing activities, including deviation handling and proper documentation.
• Collaborate closely with IT, Quality Assurance, business stakeholders, and external vendors to resolve validation-related issues.
• Maintain validation status during system operation through change control processes and periodic reviews.
  
  

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field
• 2–4 years of hands-on experience in Computer System Validation within regulated industries
• Practical knowledge of GxP regulations and guidelines including:FDA 21 CFR Part 11EU GMP Annex 11GAMP 5
• Familiarity with risk-based validation methodologies
• S trong documentation skills with high attention to detail
• Ability to work independently as well as in cross-functional teams
• Good written and verbal communication skills in English
  
  

• Grow your career in a stable, innovative environment
• Collaborate closely with clients to deliver smart, high-quality solutions
• Make an impact in a dynamic, learning-driven environment
• Be part of a human, value-driven organization that cares