Validation Technical Writer

This job was posted by https://www.kansasworks.com : For moreinformation, please see: https://www.kansasworks.com/jobs/13549126The Validation Technical Writer supports validation, quality, andoperations teams by developing clear, compliant, and audit-readydocumentation for 503B pharmaceutical manufacturing. This role ensuresall validation-related records meet FDA, cGMP, and industry standards.**Key Responsibilities** Develop, revise, and format validation documents, includingprotocols (IQ/OQ/PQ), reports, SOPs, master plans, and changecontrols. Translate technical information from SMEs, engineers, and qualitystaff into accurate, user-friendly documents. Ensure documentation aligns with 503B regulatory requirements, cGMP,and internal quality systems. Maintain document consistency, traceability, and data integrityacross validation lifecycle documents. Support audit readiness and respond to documentation-relatedinquiries during inspections. Collaborate with cross-functional teams to ensure timely completionand approval of validation documents. Track document progress and manage version control within electronicquality systems (eQMS).