Technology Transfer Specialist

2 weeks ago

Candiac, Quebec, Canada Pharmascience Full time
Job Description

The Technology Transfer Specialist will play a crucial role in the expansion of our sterile facility, ensuring the seamless transfer of injectable products and processes. This individual will be responsible for developing and adapting production processes for the transfer of products from our current line to the new vial filling line.

Key Responsibilities
  • Process Development and Transfer
    • Establish and improve existing processes in the expansion rooms as required.
    • Develop a 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.
  • Project Coordination and Execution
    • Plan, coordinate, and execute various studies for the transfer of products to the new vial filling line (compatibility, feasibility, capability studies, holding times, recirculation, purging, etc.) according to project deadlines.
    • Perform freeze-drying cycles of products on new equipment.
  • Process Optimization and Documentation
    • Develop new processes linked with new equipment (use of RTP ports, aseptic techniques under isolator, in-situ integrity tests of filters and gloves, etc.) according to project timelines.
    • 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 transfer in the expansion.
  • Training and Support
    • Train and support production employees, supervisors, and specialists from other departments on new processes.
    • Support production during the manufacturing of engineering, validation, and submissions batches.
  • Quality and Compliance
    • 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.
  • Health and Safety
    • Apply and ensure compliance with Health & Safety rules.
Requirements
  • Teamwork and Autonomy
    • Good aptitude for teamwork, autonomy, and sensitivity to client needs.
  • Technical Skills
    • 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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