CSV Engineer

3 weeks ago

Bengaluru, India VRR Life Sciences Full time
Job Title: CSV Executive
Location: Bangalore
Experience: 2-4 years
Industry: Pharmaceutical / Biotechnology / Lifesciences
Key Responsibilities:
Perform validation activities for GxP computerized systems (planning, risk assessment, URS, IQ, OQ, PQ, summary reports)
Prepare and review validation documentation in line with 21 CFR Part 11, EU Annex 11, and other regulatory guidelines
Conduct impact assessments and periodic reviews for existing validated systems
Support audits and inspections by presenting CSV documentation and processes
Collaborate with QA, IT, and business users to ensure validation deliverables are met within timelines
Guide project teams on validation requirements and risk-based approaches
Ensure data integrity compliance across systems and processes
Key Requirements:
2-4 years of hands-on experience in computer system validation within pharmaceutical, biotech, or life-sciences industries
Strong knowledge of GxP regulations, 21 CFR Part 11, EU Annex 11, and data integrity requirements
Excellent documentation and communication skills
Ability to work independently and in cross-functional teams

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