Csv Validation Engineer

Bahwan CyberTek; Ahmedabad District, Chennai District, Bengaluru; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Bahwan CyberTek is seeking an experienced CSV professional to join our life sciences validation team in Ahmedabad. You will apply 8+ years of Computer System Validation expertise within pharma or related industries to ensure compliant, audit-ready systems.

You will prepare and review Validation Plans, Risk Assessments, URS, FS, IQ/OQ/PQ, SIT, UAT, and Validation Summary Reports, and support SAP validation efforts from testing through go-live in a regulated environment.

Qualifications

• 8+ years of experience in CSV within pharma or life sciences.
• Strong knowledge of GxP, FDA requirements, and compliance standards.
• Experience in preparing, reviewing, and approving validation deliverables.
• Expertise in regulatory compliance, audit readiness, data integrity, and lifecycle validation.
• Support validation strategy, testing, reviews, defect management, go-live readiness, and SAP validation.

Responsibilities

• Prepare and review Validation Plans, Risk Assessments, URS, FS, and Traceability Matrix.
• Create IQ/OQ/PQ, SIT, UAT, and Validation Summary Reports.
• Ensure audit readiness and regulatory compliance throughout projects.
• Support SAP validations from testing through go-live in regulated environments.

Skills

Computer System Validation

GxP compliance

FDA requirements

Audit readiness

Data integrity

Validation documentation

SAP validation

Testing execution

Tools

SAP

Job description

8+ years of experience in Computer System Validation (CSV) within the pharmaceutical or life sciences industry.

Strong knowledge of GxP regulations, FDA requirements, and industry compliance standards governing validated systems.

Proven experience in preparing, reviewing, and approving validation deliverables, including Validation Plans, Risk Assessments, URS, FS, Traceability Matrix, Test Scripts, IQ/OQ/PQ, SIT, UAT, and Validation Summary Reports.

Expertise in ensuring regulatory compliance, audit readiness, data integrity, and system validation throughout the project lifecycle.

Capable of supporting validation strategy, testing execution, compliance reviews, defect management, document signoffs, go-live readiness, and hyper care support for SAP implementations in a regulated environment.

Work from Office 5 days in a week and 2 Saturdays in a Month - Ahmedabad