Computer System Validation (CSV) Engineer

Job Title: CSV Consultant Location: California (Onsite) Duration: Contract Overview: Seeking an experienced CSV Consultant to support multiple validation and remediation initiatives across pharmaceutical systems and platforms. The role involves leading validation activities, supporting data migration projects, managing change controls, and collaborating with cross-functional teams to maintain GxP compliance across validated systems. Required Qualifications: • Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field • 5+ years of CSV experience within pharmaceutical or life sciences environments • Strong experience with Veeva Platform validation including QMS, CTMS, RIM, or Quality Docs • Experience authoring and owning validation deliverables, including URS, IQ/OQ/PQ, UATs, and test scripts • Hands-on experience with Change Control processes and validation lifecycle management • Experience supporting data migration projects, including data mapping, conversion, validation planning, and documentation • Knowledge of GxP regulations, 21 CFR Part 11, and GAMP 5 • Strong stakeholder communication and documentation skills • Proficiency with Microsoft Office Suite Key Responsibilities: • Lead validation activities for multiple GxP systems and applications • Author and execute validation documentation, protocols, and test scripts • Gather and document business and system requirements for URS • Manage change controls and ensure compliance throughout the validation lifecycle • Support data migration planning, execution, and validation activities • Collaborate with quality, IT, and business stakeholders on remediation and enhancement projects • Provide project status updates and participate in cross-functional meetings • Ensure validated systems remain compliant with regulatory standards Preferred Qualifications: • Experience with SAS Studio validation • Knowledge of AWS-hosted environments • Experience with CTMS Medidata, TraceLink, and Argus • Prior experience supporting pharmaceutical system remediation projects