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Process Technical Writer 5

Capsugel | Lonza · Portsmouth, US

Writing types
Regulatory
Seniority
Mid

About the role

Responsibilities

  • Author, review, and update batch records and GMP documentation
  • Coordinate document timelines and support on-time delivery
  • Partner with cross-functional teams on regulatory and business requirements
  • Manage document review comments and incorporate feedback
  • Support project meetings across multiple customer programs
  • Mentor technical writers through peer reviews and coaching
  • Drive continuous improvement in document quality and compliance

Requirements

  • Bachelor's degree or equivalent experience; scientific discipline preferred
  • 5+ years in manufacturing, biotechnology, pharmaceutical or related environment
  • Experience creating or managing GMP documentation and batch records
  • Strong understanding of cGMP principles
  • Ability to manage multiple projects and critical deadlines
  • Strong written communication and organizational skills
  • Experience with Microsoft Office and document management systems

Benefits

  • Medical, dental, and vision insurance
  • Opportunities for professional growth and development

About the Company

Lonza operates 30+ sites across five continents, manufacturing the medicines of tomorrow.

Listed via Career sites