Job Title

This job was posted by : For moreinformation, please see: 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, including protocols (IQ/OQ/PQ), reports, SOPs, master plans, and change controls.- Translate technical information from SMEs, engineers, and quality staff into accurate, user-friendly documents.- Ensure documentation aligns with 503B regulatory requirements, cGMP, and internal quality systems.- Maintain document consistency, traceability, and data integrity across validation lifecycle documents.- Support audit readiness and respond to documentation-related inquiries during inspections.- Collaborate with cross-functional teams to ensure timely completion and approval of validation documents.- Track document progress and manage version control within electronic quality systems (eQMS).