Aseptic Process Technician - Cleanroom GMP, 12-Month

Prollenium Medical Technologies Inc.; Aurora; On-site; CAD 55,000 - 76,000; Full time

Job summary

Prollenium Medical Technologies Inc. in Aurora, Canada, is seeking an Aseptic Process Technician to join the manufacturing team in an ISO5 Cleanroom.

The role involves material preparation, line clearance, formulation, aseptic filling, and final sterilization, with emphasis on equipment setup and routine troubleshooting. You will ensure GMP/ISO13485 compliance, participate in equipment qualification, changeovers, process validation, and documentation, plus inventory management and

Qualifications

• Three-year college diploma in a scientific field (or equivalent).
• Experience in GMP/GLP or ISO compliant environment in Manufacturing, QC, QA, R&D or other technical function.

Responsibilities

• Adhere to GMP and ISO13485 quality systems.
• Perform line clearance and manufacturing clean-up in Clean Room.
• Participate in installation, operation and qualification of manufacturing equipment.
• Participate in process validation, problem solving and quality improvement projects.
• Perform production processes including formulation, milling, degassing, filling and sterilization as per master batch instructions.
• Equipment calibration and preventive maintenance; maintain documentation.
• Write SOPs and manufacturing records.
• Inventory management and stock control; order tracking and labeling.
• Coordinate manufacturing setup with QC, QA and R&D; communicate with suppliers for material concerns.

Skills

GMP/GLP experience

ISO compliant environment

Clean Room operations

Documentation

Education

Three-year college diploma in a scientific field

Tools

IQ/OQ/PQ qualification experience

Calibration systems setup

Job description

Prollenium Medical Technologies Inc. in Aurora, Canada, is seeking an Aseptic Process Technician to join the manufacturing team in an ISO5 Cleanroom.

The role involves material preparation, line clearance, formulation, aseptic filling, and final sterilization, with emphasis on equipment setup and routine troubleshooting. You will ensure GMP/ISO13485 compliance, participate in equipment qualification, changeovers, process validation, and documentation, plus inventory management and