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Manufacturing Technician
4 months ago
Position Title : Manufacturing Technician
Technician Reports to: Manufacturing Manager
Purpose Statement:
The Manufacturing technician will be primarily assigned to one of the following areas: Fractionation, Purification, Fill/Finish or Packaging but will be expected to develop multi-disciplinary skills by alternating to other areas of Manufacturing to assist with business demands. The Manufacturing technician is working in a manufacturing environment regulated by cGMPs, SOPs, safety procedures and all company policies/regulations.
Key Duties and Responsibilities:
Set up, operation and cleaning the following equipment (depending on the designated Manufacturing area): Buffer Preparation Skids, Centrifuge, Fractionation Skids and Filter presses, TFF Skids and columns, Chromatography Skids, Filtration Skids and Filling line (within an isolator)
Set up and operation: CIP/ SIP Skids, Autoclaves and Parts Washers
Execution of all Manufacturing batch records in the designated areas based on the training completed within that area
Escalation of all of issues potentially impacting cGMP of the respective Manufacturing area and or Manufacturing process to the responsible manager immediately
Participate in all Manufacturing activities related to the assigned area including sampling (process and cleaning validation, environmental monitoring, clean utilities), in-process testing, weighing, calibration and maintenance of equipment (pH meter...)
Actively participate in writing and implementing GMP documents (SOPs, batch records) using the change control system and maintain records of all necessary information/data as per GDPs
Execute daily, weekly and monthly cleaning in the respective Manufacturing area following the applicable standard operating procedures
Ensure all Manufacturing supplies within the respective Manufacturing area are maintained and replenished as required
Qualifications :
High School Diploma. CEGEP/College diploma in pharmaceutical technology or University degree in Engineering or Science preferred.
Minimum 1-year experience within the biopharmaceutical, pharmaceutical, healthcare industry is preferred.
Ability to work in a fast-paced environment and manage multiple priorities
Ability to work independently as well as in a team environment
Must be able to lift at least 15kg and wear PPE as required
Some tasks will involve working in a refrigerated environment
Experience in clean room operation is an asset
Bilingualism (French and English) both spoken and written
