CSV Analyst

Computer System Validation (CSV) Specialist / Validation Engineer Overview We are seeking an experienced Computer System Validation (CSV) Specialist to support validation activities for computerized manufacturing systems and laboratory instruments within a regulated environment. This role is responsible for leading validation efforts end-to-end, ensuring systems meet regulatory, data integrity, security, and business requirements in accordance with GxP and 21 CFR Part 11 expectations. Key Responsibilities - Lead validation projects for computerized manufacturing systems and laboratory instruments from planning through execution and approval. - Collaborate with business process owners, IT, software development teams, and Quality representatives. - Assess computerized systems for intended use, data integrity, security, and compliance impact. - Author validation documentation including Validation Plans, Requirements Specifications, Design Specifications, Test Protocols, and Validation Summary Reports. - Develop Security Plans, Business Continuity Plans, and supporting procedures. - Execute and document validation testing activities. - Investigate and resolve deviations, test failures, and validation issues. - Ensure compliance with corporate policies, site procedures, GxP requirements, and 21 CFR Part 11. Required Qualifications - Experience performing Computer System Validation in regulated environments. - Strong knowledge of GxP, 21 CFR Part 11, and data integrity principles. - Proven experience authoring and executing validation documentation. - Strong collaboration and communication skills. Preferred Qualifications - Experience with manufacturing or laboratory systems. - Familiarity with SDLC and change management. - Experience supporting audits or inspections.