Aseptic Process Specialist

21 hours ago


Candiac, Quebec, Canada Pharmascience Full time
Job Description

The Aseptic Process Specialist will be responsible for ensuring the transfer of existing processes to the expansion area, improving them as required. This includes developing filtration strategies in grade C and introducing new consumables into the injectable plant.

Key Responsibilities:

  • Establish and implement process improvements in the expansion area
  • Develop and execute filtration strategies in grade C
  • Ensure the transfer of weighing for injectable products into the weighing isolator
  • Plan, coordinate, and execute various studies for product transfer to the new vial filling line
  • Perform freeze-drying cycles of products on new equipment
  • Develop new processes linked with new equipment
  • Write protocols, reports, and technical notes related to product transfer
  • Prepare side-by-side comparisons of processes between current and transferred processes
  • Contribute to manufacturing process optimization and BOM updates
  • Support production during engineering, validation, and submissions batches
  • Train and support production employees on new processes
  • Support aseptic manufacturing and filling simulations
  • Act as a content expert for procedures regarding injectable equipment and processes
  • Participate in investigations following deviations and non-conformities

Requirements:

  • Good teamwork, autonomy, and client needs awareness
  • Ability to write and interpret technical documents
  • Effective time and priority management
  • Ability to manage multiple folders simultaneously
  • Continuous process improvement approach
  • Problem-solving skills
  • Excellent communication and interaction skills
  • Proficient with MS Office
  • Good knowledge in aseptic area

Estimated Salary: $90,000 - $120,000 per year


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