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Validation Technical Writer

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Fagron

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Location:
United States , Wichita

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Contract Type:
Not provided

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Salary:

Not provided

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.

Job Responsibility:

  • 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)

Requirements:

  • 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 we offer:
  • competitive salary
  • comprehensive benefits
  • performance package
  • ability to be part of an international leader in an expanding industry

Additional Information:

Job Posted:
April 05, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:

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