Computer Systems Validation (CSV) Engineer – Veeva Vault

Location:

Employment Type:

Position Overview

Computer Systems Validation (CSV) Engineer

Key Responsibilities

• Lead and execute end-to-end Computer Systems Validation activities in accordance with GxP, 21 CFR Part 11, Annex 11, GAMP5, and applicable regulatory standards.
• Independently develop and maintain validation documentation including, but not limited to, Validation Plans, URS, FRS, Risk Assessments, RTM, IQ/OQ/PQ protocols, test scripts, deviation management, and Final Validation Reports.
• Perform validation activities for

  Veeva Vault applications

  , including enhancements, configurations, and system updates.
• Support release management processes, including impact assessments and validation readiness activities.
• Conduct

  Gap Analysis

  to identify compliance risks and recommend/implement remediation strategies.
• Ensure systems remain audit-ready and support internal and external regulatory inspections as required.
• Collaborate effectively with cross-functional stakeholders across US and UK teams, including Quality, IT, Business, and Compliance organizations.

Required Qualifications

• Minimum 10

  years of hands-on experience

  in Computer Systems Validation within the pharmaceutical, biotechnology, or life sciences industry.

• Mandatory experience in validating Veeva Vault platforms

  .
• Strong knowledge of GxP regulations, 21 CFR Part 11, Annex 11, and GAMP5 principles.
• Demonstrated ability to independently author and execute all validation lifecycle documentation without reliance on additional support.
• Proven track record as an

  individual contributor

  in a highly regulated environment.
• Prior experience working with

  US and/or UK cross-functional teams

  .
• Excellent written and verbal communication skills, with strong attention to detail and documentation quality.

Preferred Qualifications

• Experience supporting

  Release Management

  initiatives.
• Experience conducting

  Gap Analysis

  and compliance remediation planning.