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

• Perform QA review and approval of computerized system validation deliverables (IQ/OQ/PQ, VSR, etc.).
• Ensure compliance with GxP, Data Integrity, and regulatory requirements.
• Participate in risk assessments and validation strategy discussions.
• Provide QA oversight for system lifecycle activities (implementation, periodic review, upgrade, migration, retirement).
• Support investigations, deviations, and CAPAs related to computerized systems.

Requirements

• B.Sc. in Engineering, Life Sciences, Computer Science, or a related field

• 1-3+ years of experience in QA and/or computerized systems validation in the pharmaceutical, biotech, or medical device industry.
• Experience reviewing validation documents and quality records.
• Familiarity with GMP-regulated environments.

Technical Knowledge

• Computerized system validation (CSV)
• Data Integrity principles (ALCOA+)
• GAMP 5
• EU Annex 11
• 21 CFR Part 11
• Change Control, Deviations, CAPA

Key Skills

• Strong critical thinking and analytical skills
• Attention to detail
• Ability to review complex technical documentation
• Good communication and interpersonal skills
• Ability to work cross-functionally with IT, QA, and laboratory teams

Preferred Qualifications (Advantage)

• Experience in audits or regulatory inspections
• Experience with infrastructure or cloud validation
• Knowledge of CSA (Computer Software Assurance) approach