Validation Lead- Veeva Functional Expert

Note: Only W2 - No C2C Job Title: Validation Lead- Veeva Functional Expert Duration 6 months Location: South San Francisco, CA (Remote/Hybrid) JOB DESCRIPTION Position Summary: We are seeking a detail-oriented and experienced Technical and Validation Specialist to support GxP-regulated applications within our organization. This role is critical in ensuring the integrity, compliance, and operational efficiency of systems that support regulated business processes, including quality, regulatory, and clinical operations. This person is responsible for addressing over testing- while working with test engineers to optimize testing & justify through documentation. Key Responsibilities: • Provide technical support and management for GxP applications, including installation, configuration, upgrades, and troubleshooting. • Collaborate with Quality Assurance, Regulatory Affairs, Clinical Operations, and other departments to ensure systems meet compliance requirements (e.g., 21 CFR Part 11, GAMP 5). • Validation of computerized systems, including authoring and executing validation documentation like Validation Plan, Requirement Specifications, IQ/OQ/PQ, etc. • Support change management, deviations, and CAPA processes, including impact assessments, documentation updates, and implementation coordination. • Support regulatory audits and inspections, providing technical expertise and documentation as needed. • Maintain system documentation, including SOPs, user guides, and training materials. • Monitor system performance and ensure timely resolution of issues, working closely with vendors and internal stakeholders. Qualifications: • Bachelor’s degree in Computer Science, Information Systems, Life Sciences, or related field. • 5+ years of experience supporting GxP applications in a pharmaceutical, biotech, or life sciences environment. • Experience with Veeva Vault products in Quality, Regulatory and Clinical spaces. • Strong understanding of regulatory requirements (FDA, EMA, etc.) and validation practices. • Familiarity with ITIL practices and service management tools. • Excellent problem-solving, communication, and documentation skills. • Ability to work independently and collaboratively in a fast-paced, cross-functional environment. • Preferred Qualifications: • Experience with supporting validation of a wide range of applications in pharmaceutical environment. • Knowledge of data integrity principles and cybersecurity best practices. • Experience in supporting audits and regulatory inspections. Required Skillset The must haves! • Veeva Vault Quality applications are a MUST • Preferred- Veeva for Regulatory and Clinical • (keywords that our recruiters use for their search) • Leadership, overseeing & utilizing test engineers