Validation Technical Writer
Fagron Group, Wichita, KS, United States
About the Job
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).
Basic Qualifications
Bachelor’s degree in a scientific, engineering, or technical discipline (or equivalent experience).
2+ years of experience in pharmaceutical, biotech, or 503B sterile compounding environments.
Strong understanding of validation principles, cGMP, and FDA guidance.
Excellent technical writing, editing, and organizational skills.
Ability to work independently and manage multiple documents in a fast-paced, regulated environment.
What's on Offer? We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional, and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.
Ready for the challenge? Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, creed, color, religion, national origin, sex, age, disability, sexual orientation, gender identity or expression, genetic predisposition or carrier status, veteran, marital, or citizenship status, or any other status protected by law. Fagron US is proud to be an affirmative action and equal opportunity employer.
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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).
Basic Qualifications
Bachelor’s degree in a scientific, engineering, or technical discipline (or equivalent experience).
2+ years of experience in pharmaceutical, biotech, or 503B sterile compounding environments.
Strong understanding of validation principles, cGMP, and FDA guidance.
Excellent technical writing, editing, and organizational skills.
Ability to work independently and manage multiple documents in a fast-paced, regulated environment.
What's on Offer? We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional, and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.
Ready for the challenge? Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, creed, color, religion, national origin, sex, age, disability, sexual orientation, gender identity or expression, genetic predisposition or carrier status, veteran, marital, or citizenship status, or any other status protected by law. Fagron US is proud to be an affirmative action and equal opportunity employer.
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