CSV Engineer (Hojai)

Job Title: CSV Engineer Location: Bangalore Experience: 1 -7 years Industry: Pharmaceutical / Biotechnology / Lifesciences About the Role: We are looking for an experienced Computer System Validation (CSV) skilled to support validation activities for GxP-regulated computerized systems. The role involves executing validation deliverables, ensuring regulatory compliance, and working closely with cross-functional teams to maintain system integrity throughout the lifecycle. Key Responsibilities
- Perform validation activities for GxP computerized systems (planning, risk assessment, summary reports).
- Prepare and review validation documentation including URS, FRS, RA, IQ, OQ, PQ, and Traceability Matrix.
- Support validation of systems such as LIMS, QMS, ERP, MES, CDS, and laboratory instruments.
- Contribute to SOP creation and updates related to computerized systems.
- Execute and support CSV activities in line with GAMP 5, 21 CFR Part 11, EU Annex 11, and company SOPs.
- Perform risk assessments and data integrity evaluations.
- Support change control, periodic reviews, and deviation management for validated systems.
- Participate in regulatory audits and inspections and provide CSV-related responses.
- Conduct impact assessments and periodic reviews for existing validated systems.
- Collaborate with QA, IT, and business users to ensure validation deliverables are met within timelines.
- Ensure data integrity compliance across systems and processes. Key Requirements
- Bachelors or Masters degree in Lifesciences, Pharmacy, Biotechnology, or related field.
- 1 -7 years of hands-on experience in Computer System Validation within regulated environments.
- Strong understanding of regulatory requirements and guidelines (GAMP 5, 21 CFR Part 11, EU Annex 11)Experience with validation of ERP, LIMS, QMS, or other laboratory/manufacturing systems preferred.
- Experience validating GxP systems and laboratory equipment.
- Excellent documentation and communication skills.
- Ability to work independently and in cross-functional teams.
- Familiarity with data integrity principles (ALCOA+). Apply on Kit Job: kitjob.in/job/4m5icy