CSV ENGINEER

Hiring: CSV Consultant (Hybrid – CA) We are seeking an experienced Computer System Validation (CSV) Consultant to support a pharmaceutical client in CA. This is a hybrid role requiring onsite presence 3–4 days per week. The ideal candidate will have strong experience in Veeva platform validation, data migration, and end-to-end ownership of validation deliverables. Key Responsibilities: • Execute and manage validation activities for Veeva Vault applications, including QMS, CTMS, RIM, and Quality Docs • Develop and execute User Acceptance Testing (UAT), including authoring detailed test scripts and test cases • Independently author, review, and manage validation lifecycle documentation such as URS, risk assessments, validation plans, protocols, and summary reports • Collaborate with cross-functional teams including Quality, IT, Regulatory, and Business stakeholders to ensure compliance and timely delivery • Gather and document user and system requirements, translating business needs into User Requirements Specifications (URS) • Manage Veeva Change Control processes, including initiation, assessment, implementation, and closure • Support and lead data migration activities, including defining migration strategy, identifying tools, ensuring data integrity, and preparing required documentation • Ensure all validation activities comply with GxP, FDA, and industry regulatory standards Required Qualifications: • Prior experience working as a CSV Consultant within the pharmaceutical or life sciences industry • Hands-on experience with Veeva Vault platform (QMS, CTMS, RIM, or Quality Docs) • Strong understanding of the computer system validation lifecycle and regulatory requirements (GxP, 21 CFR Part 11) • Experience in writing and executing validation documentation (URS, IQ/OQ/PQ, UAT) • Proven experience supporting data migration projects and system implementations • Ability to work independently, manage multiple deliverables, and communicate effectively with stakeholders Work Model: Hybrid role based in CA (3–4 days onsite per week)