Computer System Validation Lead Consultant

Position: CSV Lead Consultant

Location: Alameda, CA (Hybrid, 3 days/week onsite)

Position type: Multi year engagement

This is a hybrid role for a CSV Lead located in Alameda, CA with some flexibility for remote work. The individual will oversee computerized system validation efforts, ensuring compliance with regulatory and quality standards. Key tasks include planning, developing, and executing validation strategies for systems such as Veeva Vault and other Life Sciences technologies. The role also involves leveraging automation tools, collaborating with cross-functional teams for validation deliverables, and providing expertise to maintain and enhance GxP compliance.

Qualifications

• Lead and performs risk-based validation of GxP systems, develops validation documents using defined CSV process, and communicates project progress throughout the system lifecycle.
• Looking for experience in systems like Veeva Vault (RIM, QMS, QDocs), Trackwise, Tracelink, eQMSe, SAS, Argus, LIMS etc.
• Validates system implementations, system upgrades and creates system documentation in accordance with computerized system validation plan and protocols.
• Facilitates verification and validation activities such as User Acceptance Testing (UAT), test execution, documentation review, and approval.
• Oversee and take part in the formal test execution of IQ, OQ and PQ to ensure the testing was performed appropriately and the test results are compiled in a timely manner.
• Work collaboratively across functions with Quality, IT, Business, and Vendors to plan, coordinate and execute computer system validation activities, and obtain fully approved documents.
• Proficiency in Programming for creating scripts and automation solutions.
• Leadership and teaching skills for managing and guiding teams on validation protocols and GxP compliance.
• Strong understanding of regulatory compliance (e.g., FDA, EU Annex 11).
• Excellent analytical and problem-solving abilities.
• Bachelor s degree in Computer Science, Life Sciences, or a related field.
• Experience with validation automation tools is preferred.