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Spotline • South San Francisco, California, United States
Role & seniority: Computer System Validation Lead (senior contractor)
Location & work type: South San Francisco, CA; Hybrid (3 days onsite/week); multi-year contract
Stack/tools (experience desired): Veeva Vault; Trackwise; Tracelink; eQMS; SDFC (and other Life Sciences systems); validation automation tools; scripting/automation for validation
Lead risk-based validation of GxP systems; develop/execute validation strategies and documents per CSV plans and protocols
Oversee/participate in IQ/OQ/PQ testing, UAT, test execution, documentation review, and timely compilation of results
Collaborate cross-functionally (Quality, IT, Business, Vendors) to plan, coordinate, and obtain fully approved validation deliverables; ensure GxP/regulatory compliance
Strong understanding of regulatory compliance (FDA, EU Annex 11)
Risk-based validation approach for GxP systems
Proficiency in scripting/automation for validation solutions
Experience creating/maintaining CSV documents and validation packages
Ability to guide teams on validation protocols and GxP compliance
Excellent analytical and problem-solving abilities
Experience with validation automation tools
Teaching/mentoring or leadership in validation contexts
Bachelor’s degree in Computer Science, Life Sciences, or related field (explicitly listed as qualification)
Computer System Validation Lead South San Francisco, CA (Hybrid, 3 days/week onsite) Multi year long term contract Role Description This is a contract-based hybrid role for a Computer System Validation Lead, located in South San Francisco, 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, Trackwise, Tracelink, eQMS, SDFC 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. Teaching skills for 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.