Validation Technical Writer: FDA-Ready Docs & eQMS

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

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.