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Technical Documentation Specialist

2 months ago

Windsor, Ontario, Canada BioVectra Full time

The Technical Writer will play a crucial role in developing and maintaining technical documents that directly support manufacturing and special projects at BioVectra.

Main Responsibilities:

  • Develop and manage technical documents that support manufacturing and special projects.
  • Collaborate with the project team to identify specifications and requirements for materials and equipment.
  • Ensure documentation meets compliance under cGMP guidelines.
  • Communicate with suppliers and internal teams to ensure alignment of technical documents.
  • Prepare validation protocols, reports, and documentation for successful project execution.
  • Provide training and orientation for manufacturing employees on standard operating procedures.
  • Facilitate continuous improvement and best practice development within the Production unit.
  • Prepare spreadsheets to track critical project data and identify process improvement opportunities.
  • Source and purchase equipment and process aids for API processes.
  • Adhere to BioVectra's Health and Safety Policy.

Requirements:

  • Postsecondary education in technology, science, or a related field.
  • Two years' experience in the pharmaceutical industry.
  • Familiarity with Q7A guidance and ability to apply it to project requirements.
  • One year of technical writing experience considered an asset.

BioVectra offers a competitive salary and benefit package to the successful candidate.