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
