Company Description

Traferox creates, manufactures and commercializes products used to transplant solid organs (lungs, heart, liver, kidneys, pancreas). These products employ technologies invented by the transplant surgeons at the University Health Network (UHN). Traferox currently sells the TorEx Lung Perfusion System and the X OPort Lung Transport Device. Traferox Technologies is committed to improving the outcomes of organ transplants and to save patients’ lives.

Traferox Technologies Inc.

Job Description

Union: Non-Union
New or Replacement: New
Department: Manufacturing
Site: 2400 Skymark Ave. Mississauga, Ontario
Reports to: Manager
Wage Range: $22.00 - $23.00 per hour
Hours: 37.5 Hours per Week
Status: Permanent Full-time
Closing Date: Open Until Filled

The Microbiology Technician supports routine microbiology -related manufacturing activities, environmental monitoring, sample management, testing coordination, documentation, and contamination control activities in compliance with GMP, applicable SOPs, and regulatory requirements.

Primary duties

• Perform environmental monitoring sampling of manufacturing, cleanroom, and other controlled manufacturing areas, including viable and non-viable monitoring, as applicable.
• Collect personnel, surface, air, compressed gas, water, and other microbiological samples according to approved procedures.
• Perform routine microbiological testing, as applicable, including bioburden, sterility support testing, endotoxin, microbial limits, water testing, and product or process-related microbiological testing.
• Receive, label, log, store, ship, and track microbiological and sterility testing samples in accordance with sample handling requirements.
• Coordinate with external laboratories and supply chain teams for third-party testing, sample submission, materials, and test result follow-up.
• Analyze, document, and report microbiological and environmental monitoring results.
• Enter and maintain microbiology data in approved forms, and spreadsheets.
• Escalate OOS, OOT, adverse trends, contamination events, and deviations to management and Quality Assurance.
• Support investigations related to OOS, OOT, deviations, contamination events, EM excursions.
• Support CAPA implementation, effectiveness checks, and follow-up actions as assigned.
• Maintain inventory of microbiology supplies, media, reagents, consumables, and laboratory materials.
• Follow GMP, GLP where applicable, GDP, safety procedures, contamination control procedures, and approved SOPs.
• Support continuous improvement activities related to microbiology, contamination control, laboratory efficiency, and data integrity.

Additional duties, as required

• Support cleanroom qualification, requalification, and environmental monitoring program assessments.

• Support cleanroom cleaning and disinfection activities

• Perform or support trending of environmental monitoring, bioburden, and other microbiological data.

• Coordinate with QA, Production, Validation, Engineering, Facilities, and Supply Chain on microbiology-related activities.

Qualifications

Education

• High school diploma required.
• College diploma or certificate in Microbiology, Biotechnology, Biology, Medical Laboratory Technology, Chemical Laboratory Technology, or related field preferred.

Experience

• 1–2 years of laboratory, manufacturing, cleanroom, medical device, pharmaceutical, biotech, food, or regulated industry experience.

• Prior microbiology lab experience preferred, but not required if the candidate has strong documentation skills and can follow procedures.

• Experience with environmental monitoring, aseptic technique, sample handling, or GMP documentation is an asset.

Additional Information

We thank all applicants for their interest in this position with Traferox Technologies Inc. Please note that only candidates selected for an interview will be contacted.