Summary: Engage on CSV Projects as a key team member and drive CSV deliverables. Provide guidance and support to ensure computerized systems are deployed following lifecycle management and remain in a validated state per associated SOPs, regulatory and security requirements Responsibilities will include, but not necessarily limited to the following: *Provide strategic leadership and decision making on CSV strategy using risk-based approach. *Develop CSV strategies for different systems/applications including validation of AI Tools/Applications. *Provide oversight and manage multiple projects at the same time. Drive CSV deliverables in the projects. *Author CSV Documents (Validation Plans and Summary Reports) *Assist/co-author requirements, UFRS/FRS, IQ, OQ, PQ protocol scripts, specifications, and other validation project deliverables *Ensure training requirements are complete for project team members (CSV SOP, Test Execution, Gdoc. Etc.) *Guide project team members on CSV projects ensuring team members follow laid out CSV plans *Provide real-time oversight and support during test execution and review executed protocols *Route CSV documents for approval(s) * Manage & maintain CSV documents in Veeva *Train, coach, and mentor GxP system owners. Skills: 5-10+ years’ hands on experience in a validation role with responsibility for computer systems specifically Veeva systems – Veeva Quality, Veeva QMS, Veeva RIMS, and other systems. Experience in validation of GAMP Category 5 (custom-built/bespoke) systems. Experience with AI Tools/Applications and assessing GxP relevance of the AI use case. Solid working knowledge of CSV guidelines and FDA/EU regulations: 21 CFR Part 11, Annex 11, GAMP 5, GMPs, Good Clinical Practices, Data Integrity. Strong technical writing skills for authoring, reviewing and approving validation plans, requirements, testing documents and summary reports. Knowledge and understanding of the FDA Computer Software Assurance (CSA) fundamental concepts. Strong customer service skills for internal and external customers. Ability to multi-task on different projects and prioritize efforts effectively. Education: Bachelor’s in Computer Science, Engineering, Life Sciences, or a related field. Pay Range: $80-92/hr *based on experience