Validation Technical Writer

Fagron Sterile Services US (FSS); Wichita (KS); On-site; USD 70,000 - 90,000; Full time

Job summary

Fagron Sterile Services US (FSS) is seeking a Validation Technical Writer in Wichita, Kansas. In this role, you will support validation, quality, and operations teams by creating clear, compliant documentation for 503B pharmaceutical manufacturing. Responsibilities include developing validation documents, ensuring regulatory compliance, and maintaining document integrity. Ideal candidates have prior experience in the pharmaceutical industry, a strong understanding of FDA and cGMP standards, and excellent communication skills for translating technical information.

Qualifications

• Experience in developing validation documents for pharmaceutical manufacturing.
• Strong understanding of FDA and cGMP regulations.
• Ability to translate complex technical information into user-friendly documentation.

Responsibilities

• Develop, revise, and format validation documents, including protocols and SOPs.
• Ensure documentation aligns with regulatory requirements and internal quality systems.
• Collaborate with teams to ensure timely approval of validation documents.

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).