Job Description

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 XPort Lung Transport Device.Traferox Technologies is committed to improving the outcomes of organ transplants and to save patients' lives.

Work Location: 3505 Laird Road, Unit 16, Mississauga, Ontario
Work Model: On-site
Status: Permanent Full-time
Closing date: October 31, 2025
Duties and Responsibilities:

• Provide technical knowledge and leadership as the site microbiology subject matter expert (SME) (e.g. project work, resolution of deviations, method development, interface with 3rd -party laboratories).
• Provide oversight and technical knowledge to effectively manage and monitor the facility environmental quality to applicable company, regulatory and statutory requirements.
• Maintain compliance to procedures, testing, and data integrity practices.
• Conduct the environmental monitoring of cleanroom facilities for medical device assembly and aseptic filling. Includes microbial monitoring, temperature, humidity, pressure, and non-viable particulate.
• Enumeration, isolation, and identification of bacteria, yeast, and mold.
• Prepare reports and trend analysis of the environmental monitoring results. As the SME be the point person to share EM trending at all levels and prepare monthly slides for senior leadership review.
• Evaluate, order, and maintain facility supplies, media, and reagents needed for the environmental monitoring program.
• Manage and perform calibration of equipment used for microbial and particulate sampling.
• Ensure proper disposal of all microbiological waste.
• Conduct sampling of incoming raw materials using aseptic technique.
• Conduct sampling, testing and evaluation of purified water for microbial quality.
• Investigate Out-Of-Specification test results and document the investigation, root cause(s), and corrective actions.
• Provide training and guidance to employees on GMP and contamination control principles including gowning qualification.
• Write and review quality assurance procedures and documents related to environmental monitoring.
• Assist in supplier qualification activities for contract laboratories and material suppliers, including performing supplier audits.
• Interface closely with contract laboratories for outsourced testing including testing performed on site to support qualification or ongoing manufacturing activities.
• Assist the quality assurance team with tasks such as reviewing purchase order specifications, incoming inspection forms, production device history records, and nonconformance material reports.
• Other duties as assigned.

Qualifications
Education:

• University degree in microbiology, or related science discipline with evidence of completion of microbiology courses.

Experience:

• 2 years of practical working experience of working as a Microbiologist in commercial, laboratory, or research setting..
• Experience working under a quality management system (pharmaceutical or medical device) is an asset.

Skills and Knowledge:

• Working knowledge of the methods, materials, and aseptic techniques used in laboratory work.
• Working knowledge of the use of laboratory apparatus and equipment.
• Ability to communicate clearly and concisely both orally and in writing.
• Competency in clearly and fluently expressing concepts and ideas in English, orally and in writing.
• Ability to work as a member of a team and under minimum supervision.
• Ability to prepare, interpret and generate routine test reports in a timely manner and in accordance with internal and regulatory guidelines to meet timelines.
• Flexibility to work in a fast-paced environment and willing to take initiative to develop and improve processes.

Skills Required