Validation Technical Writer

About

The Validation Technical Writer supports validation, quality, and operations teams by developing clear, compliant, and audit-ready documentation for 503B pharmaceutical manufacturing. This role ensures all 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).