Technology Transfer Specialist

1 month ago

Candiac, Quebec, Canada Pharmascience Full time

The Technology Transfer Specialist plays a crucial role in the expansion of the sterile facility, ensuring the seamless transfer of injectable products and processes. This position requires a strong technical expertise in aseptic manufacturing and process development.

Key Responsibilities:

  • Develop and adapt production processes for the transfer of products from the current line to the new vial filling line.
  • Support the visual inspection and packaging automation project with technical expertise.
  • Establish the transfer of existing processes to the rooms of the expansion, improving them as required.
  • Develop the filtration strategy in grade C and introduce new consumables in the expansion of the injectable plant.
  • Ensure the transfer of weighing for injectable products into the weighing isolator.
  • Plan, coordinate, and execute the various studies for the transfer of products to the new vial filling line.
  • Perform freeze-drying cycles of products on new equipment.
  • Develop new processes linked with new equipment, such as RTP ports and aseptic techniques under isolator.
  • Write protocols, reports, technical notes, and notices of changes related to the transfer of products.
  • Prepare side-by-side comparisons of processes between the current and the transfer in the expansion.
  • Contribute to the optimization of manufacturing processes and update of the BOM.
  • Support production during the manufacturing of engineering, validation, and submissions batches.
  • Train and support production employees, supervisors, and specialists from other departments on new processes.
  • Support the execution of aseptic manufacturing and filling simulations (media fill) of new processes.
  • Act as a content expert for writing procedures regarding injectable equipment and processes, production master files, and aseptic simulations.
  • Act as a technical expert for the visual inspection and packaging automation project and support visual inspection recipe creation.
  • Participate in investigations following deviations and non-conformities observed during the qualification of new equipment.
  • Apply and ensure compliance with Health & Safety rules.

Requirements:

  • Good aptitude for teamwork, autonomy, and sensitivity to client needs.
  • Ability to write and interpret technical documents.
  • Ability to effectively manage time and priorities.
  • Ability to manage multiple folders simultaneously.
  • Continuous process improvement approach.
  • Skills in problem-solving.
  • Easy to interact and excellent ability to communicate with people.
  • Proficient with MS Office.
  • Good knowledge in aseptic area.
  • Lean Six Sigma Green Belt Certification an asset.

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