
CSV Engineer
4 days ago
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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