CSV Engineer

Summary:

We are looking for a skilled CSV Engineer with strong experience in Veeva systems to support validation, compliance, and implementation activities in a regulated life sciences environment. The ideal candidate will have hands-on experience working on Veeva platforms and ensuring systems meet GxP and 21 CFR Part 11 compliance.

Roles & Responsibilities :

• Perform Computer System Validation (CSV) activities for Veeva applications.
• Develop and execute validation documents: URS, FRS, IQ, OQ, PQ, RTM, etc.
• Ensure compliance with GxP, 21 CFR Part 11, and regulatory guidelines.
• Support validation of Veeva Vault, Veeva CRM, or other Veeva applications.
• Review and approve system changes, patches, and upgrades from a validation perspective.
• Collaborate with QA, IT, and business stakeholders to maintain validated state.
• Support audits and inspections by providing validation documentation and evidence.

Education & Experience :

• Strong experience in Computer System Validation (CSV)
• Hands-on Veeva experience (Vault / CRM / Clinical / Quality / RIM)
• Knowledge of GxP, 21 CFR Part 11, and GMP regulations
• Experience creating and maintaining validation documentation
• Excellent communication and stakeholder management skills
• Experience in life sciences or pharmaceutical domain
• Exposure to cloud-based system validation
• Understanding of SDLC & Agile environments