Technical Writer – Biopharma (Data Deviations & Tech Transfer)

Position Summary

We are seeking an experienced Technical Writer with a strong background in biopharmaceutical manufacturing to support documentation related to data deviations, investigations, and technology transfer activities. The ideal candidate will have a deep understanding of GMP environments and the ability to translate complex technical and quality information into clear, compliant documentation.

Key Responsibilities

• Author, review, and edit technical documents including:
  • Deviation reports (minor, major, critical)
  • Investigation reports (root cause analysis, CAPAs)
  • Change controls and risk assessments
  • Tech transfer documentation (protocols, reports, comparability assessments)
• Collaborate cross-functionally with Quality Assurance, Manufacturing, Process Development, and Regulatory teams to gather and verify technical content
• Ensure all documentation aligns with current GMP, FDA, and ICH guidelines
• Support data integrity initiatives by ensuring accuracy, traceability, and completeness of documentation
• Translate complex scientific and manufacturing data into clear, concise, and compliant narratives
• Participate in deviation triage meetings and provide documentation support for investigations
• Support internal and external audits by preparing and reviewing documentation
• Maintain document control standards within electronic systems (e.g., Veeva, MasterControl)

Required Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Biochemistry, Engineering, or related field
• 3–7+ years of technical writing experience in the biopharmaceutical or pharmaceutical industry
• Strong experience writing deviation reports and supporting investigations in a GMP-regulated environment
• Hands-on experience with technology transfer (process scale-up, site-to-site transfer, or method transfer)
• Solid understanding of:
  • GMP regulations (FDA, EMA)
  • Data integrity principles (ALCOA+)
  • Root cause analysis methodologies (e.g., 5 Whys, Fishbone)
• Excellent written and verbal communication skills
• Strong attention to detail and ability to manage multiple priorities

Preferred Qualifications

• Experience with biologics (e.g., monoclonal antibodies, cell/gene therapy)
• Familiarity with regulatory submissions and inspection readiness
• Experience using document management systems (e.g., Veeva, TrackWise, MasterControl)
• Knowledge of statistical analysis tools or data trending