What are the responsibilities and job description for the Computer System Validation Lead position at Spotline, Inc.?
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.