Validation Engineer

Job Description

Role: Validation Engineer (Veeva Vault expertise)

Location: San Francisco, California, United States

We are seeking an experienced Computer System Validation (CSV) Engineer with strong Veeva Vault expertise to support validation activities within a regulated pharmaceutical environment. The ideal candidate will have hands-on experience validating GxP systems and working closely with Quality, IT, and Business stakeholders to ensure regulatory compliance.

Key Responsibilities

• Perform CSV activities for GxP computerized systems in compliance with FDA, EMA, and global regulatory requirements
• Lead and execute Veeva Vault validation (QMS, RIM, eTMF, Clinical, or Safety modules)
• Develop and review validation deliverables, including:
• Validation Plans (VP)
• User Requirements Specifications (URS)
• Functional & Design Specifications (FS/DS)
• Risk Assessments (GAMP 5)
• IQ/OQ/PQ protocols and reports
• Traceability Matrix (RTM)
• Support SDLC activities including system implementation, upgrades, patches, and decommissioning
• Ensure data integrity (ALCOA+) compliance
• Support audits and inspections (FDA, internal, and client audits)
• Collaborate with Quality Assurance to address deviations, CAPAs, and change controls
• Maintain validation documentation within electronic document management systems

Required Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related field
• 4+ years of CSV experience in a regulated pharmaceutical or biotech environment
• Hands-on experience validating Veeva Vault applications
• Strong knowledge of GAMP 5, 21 CFR Part 11, Annex 11
• Experience with cloud/SaaS validation
• Excellent documentation, communication, and stakeholder coordination skills

Preferred Qualifications

• Experience with Agile or Waterfall SDLC methodologies
• Exposure to other validated systems (LIMS, QMS, ERP, MES)
• Prior experience supporting regulatory inspections
• Veeva Vault certification is a plus