IT CSV Engineer

Role: IT CSV Engineer responsible for leading validation efforts for manufacturing, quality control, enterprise, and process development systems within biopharma manufacturing and quality environments. Objectives include ensuring compliance with GxP regulations, FDA CSA principles, and GAMP5 practices, while supporting remediation and new system implementation projects. Responsibilities encompass developing validation strategies, authoring validation documents, managing risk assessments, overseeing external CSV consultants, and maintaining validated states of GxP systems. Requirements include 5+ years of GxP CSV experience, deep knowledge of 21 CFR Part 11, Annex 11, Data Integrity, and quality risk management (ICH Q9). Preferred skills involve technical writing, cross-functional collaboration, and understanding of validation/qualification concepts within pharma quality systems. High-value specifics: focus on GxP compliance, validation lifecycle management, Data Integrity, and risk-based validation approaches aligned with FDA and global standards. Work setup is hybrid in Seattle or Redmond, WA, with a focus on continuous improvement, cross-team collaboration, and compliance oversight.