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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