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Process Technician
2 months ago
Prollenium Medical Technologies Inc. is a leading manufacturer of medical devices, committed to innovation and quality. We offer competitive compensation, benefits, and development opportunities.
The Process Technician plays a crucial role in supporting manufacturing and general operations at Prollenium. Reporting to the Manufacturing Supervisor, this position is responsible for ensuring the smooth operation of our clean room facilities and manufacturing equipment.
Key Responsibilities- Adhere to GMP and ISO13485 quality systems to maintain the highest standards of quality and safety.
- Perform line clearance and manufacturing clean-up operations in the Clean Room, ensuring a clean and organized environment.
- Participate in the installation, operation, and qualification of manufacturing equipment, including filling lines, mixing, and sterilization.
- Contribute to process validation activities, problem-solving, quality improvement drives, and process improvement projects.
- Operate production processes, such as formulation, milling, dialyzing, degassing, filling, and sterilizing of manufacturing products, following master batch instructions.
- Perform equipment calibration, corrective and preventive maintenance, documentation, and maintenance of files.
- Write SOPs and manufacturing documentation to ensure compliance and accuracy.
- Manage inventory, including ordering, stock control, order tracking, and labeling.
- Communicate with suppliers for material concerns and machine issues, and perform troubleshooting when necessary.
- Coordinate manufacturing set-up projects with other departments, including QC, QA, and R&D.
- Three-year college diploma in a scientific field and 1-year work experience in a GMP/GLP or ISO compliant environment in manufacturing, QC, QA, R&D, or other technical functions.
- Excellent written and oral communication skills.
- Experience working in a Clean Room environment.
- Experience with IQ/OQ/PQ of manufacturing and/or laboratory equipment.
- Experience with calibration systems setup and performing equipment calibrations.
- Inventory management systems setup and/or management.
- SOP writing experience.