Validation Specialist

Validation Specialist Responsibilities: -Lead validation for multiple assigned projects, covering the full lifecycle from requirements through decommissioning -Develop and maintain validation plans and reports, specifications, risk assessments, and traceability matrices -Write, execute, and report on DQ, IQ, OQ, PQ, and process validation activities -Support commissioning and qualification so systems are ready for execution, including attending FAT when needed -Investigate and document deviations and engineering changes that come up during testing -Initiate or support change controls and evaluate their impact on validated systems -Create and route validation records in electronic systems such as HP ALM or Veeva -Keep project managers informed on status, risks, and escalations, and lead focused working sessions when needed -Partner with IT validation resources on computerized system projects Validation Specialist Requirements: -5+ years of Commissioning, Qualification, and Validation (CQV) experience - Pharmaceutical experience is a plus -Hands-on experience authoring and executing validation documentation, including electronic validation -Solid understanding of GMP, FDA requirements, EU Annex 15, and GAMP 5