CSV Lead

Experience Validating ERP to AWS Data migration process and Data migration validation project Experience in the Pharmaceutical, Biotechnology, or Medical Device industry – 5+ years in System Development Lifecycle 5+ years' experience in Computer System Validation, based on the role Experience in FDA and/or globally regulated environments with good understanding of GxP standards and risk-based validation Knowledge of FDA guidance and industry standards (e.g., GAMP) Proven experience in writing and executing validation documentation such as Requirements, Validation/Compliance Plans, Test Protocols, Test Summary Reports, and Validation Reports Experience reviewing system test and UAT scripts, Traceability Matrices, and Design Specifications; familiar with QA methodologies, designing, reviewing, and approving Test Plans, UAT scripts, and procedures Strong verbal and written communication skills Ability to work collaboratively in teams, lead projects, or work independently Experience working with remote teams and managing multiple projects simultaneously Ability to provide validation guidance, conduct timely reviews, and escalate issues to Technology Quality Management #J-18808-Ljbffr