at Fagron Sterile Services in Wichita, Kansas, United States
Job Description
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).
