סקירה כללית
^^משרה זו נלקחה מ INDEED^^
Date: 8 Jan 2026 Company: Qualitest Group Country/Region: IL 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 1
1. 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. Requirements: 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 Strong 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 Why should you join us? 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
דרישות המשרה
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 1
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