Job Detail

Production Technician

Job Summary

Location

Montreal QC

Posting date

Industries

  • Pharmaceutical, Biotechnology

Categories

  • Bioanalysis
  • Chemistry
  • Engineering
  • Medical and pharmaceutical information
  • Microbiology
  • Pharmacology

http://www.greencrossbt.com/careers/

Position Summary

The Production Technician is responsible for working in the production department while following cGMPs, SOPs, safety procedures and all company policies/regulations. The Production Technician will be primarily assigned to one of the following areas: fresh frozen plasma, cutting/pooling/centrifugation, fractionation, purification, fill/finish, visual inspection, or packaging but will be expected to rotate to other areas of production to assist wit business demands (buffer preparations, warehouse).

Key Duties and Responsibilities

  • Perform all duties according to the SOPs and cGMPs and all established safety standards and company policies
  • Set up, and operate the following manufacturing equipment:
    • CIP / SIP skids
    • Autoclaves
    • Parts Washers
  • Set up, operate and clean the following manufacturing equipment depending on production area:
    • Buffer Preparation Skids
    • Centrifuge
    • Fractionation skid and filter presses
    • TFF skids and columns
    • Chromatography skids
    • Filtration skids
    • Filling line within an isolator
  • Participate in all production activities related to the assigned production area including sampling (process and cleaning validation, environmental monitoring, clean utilities), in process testing, weighing, calibration and maintenance of equipment (i.e. pH meter)
  • Maintain housekeeping standards in the production area including cleaning of the production rooms
  • Document and record all necessary information/data as per Good Documentation Practices, SOPs and cGMPs requirements (i.e. observations, test results)
  • Actively participate in writing and implementing GMP documents (SOPs, batch records) using the change control system
  • Notify the production lead in a timely manner of any events that occur on the production floor especially product, quality and safety related issues
  • Coordinate with the support departments to ensure any quality, validation, maintenance issues are addressed in a timely manner
  • Assist in engineering FAT, SAT, and all related equipment qualification activities
  • Participate in projects focused on continuous improvement using Lean principles
  • Perform other duties as assigned

Qualifications

  • Education: College diploma in pharmaceutical technology or University degree in Engineering or Science
  • Ability to manage in a fast-paced environment and manage multiple priorities
  • Results oriented with attention to detail
  • Must be able to lift at least 15 kg, and wear PPE as required
  • Some tasks will involve working in a refrigerated environment
  • Experience in clean room operation is an asset
  • Proficient in English and French (written and spoken)
  • Experience in Biologics manufacturing is desirable
  • Ability to work independently as well as in a team environment

Availability: Production Technicians are expected to be willing and flexible to work rotating shifts