SAP CSV

Bahwan CyberTek; Ahmedabad District; On-site; INR 1,500,000 - 2,200,000; Full time

Job summary

Bahwan CyberTek seeks a seasoned CSV professional to lead validation in pharma/life sciences environments. You will drive GxP compliance, develop and review IQ/OQ/PQ, URS, FS, traceability matrices, and validation reports, ensuring audit readiness and data integrity throughout the project lifecycle.

Collaborating with SAP implementations in regulated settings, you will support go-live readiness, defect management, and post-launch hyper care to ensure validated systems operate compliant with FDA

Qualifications

• 8+ years of experience in CSV within pharma or life sciences.
• Strong knowledge of GxP, FDA requirements and industry standards.
• Experience in preparing and approving validation deliverables (IQ/OQ/PQ, URS, FS, TM, Test Scripts).

Responsibilities

• Support validation strategy, testing execution, and compliance reviews.
• Manage defect tracking, signoffs, and go-live readiness.
• Provide hyper care support for SAP implementations in regulated environments.

Skills

CSV experience

GxP knowledge

Regulatory compliance

Audit readiness

Data integrity

Validation lifecycle

Tools

SAP implementations

Job description

Key Requirments.

• 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.