Traferox creates, manufactures and commercializes products used for preservation, perfusion and assessment of solid organs (lungs, heart, liver, kidneys, pancreas). These products employ technologies invented by the transplant surgeons at the University Health Network (UHN). Traferox Technologies is committed to improving the outcomes of organ transplants and to saving patients’ lives.
Location:
The work will be performed in the company’s place of work at 3505 Laird Rd. Unit 16, Mississauga, Ontario L5L 5Y7, and at 2400 Skymark Ave. Unit 3, Mississauga, Ontario L4W 5K5.
Minimal travel (< 10%) is expected.
Traferox Technologies Inc.
Job DescriptionUnion: Non-Union
Number of Vacancies: 1
New or Replacement Position: Replacement
Site: 2400 Skymark Avenue, Mississauga
Department: Operations
Reports to: Vice-President, Manufacturing and Service
Salary Range: $70,000 - $80,000 annually
Hours: 37.5 Hours Per Week
Shifts: Days, Monday - Friday
Status: Temporary Full-time (12-18 month contract)
Closing Date: Open until filled
Duties and Responsibilities:
Environmental Monitoring and Aseptic Control
- Conduct the environmental monitoring of cleanroom facilities and personnel for aseptic filling production operations. Includes microbial monitoring, temperature, humidity, pressure, and non-viable particulate.
- Prepare reports and trend analysis of the environmental monitoring results related to production activities. As the SME be the point person to share EM trending at all levels and prepare monthly slides for senior leadership review.
- Plan and oversee facility and process microbiological qualification activities such as facility qualification, EMPQ, and media fills.
- Evaluate, order, and maintain facility supplies, media, and reagents needed for the environmental monitoring program.
- Investigate Out-Of-Specification test results and document the investigation, root cause(s), and corrective actions.
- 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.
- 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).
Aseptic Manufacturing Support
- Collaborate with aseptic technicians during media fills, gowning qualifications, and aseptic interventions.
- Provide microbiological input for facility and equipment qualification, EMPQ, and validation activities.
- Train manufacturing staff on microbiological principles, aseptic practices, and contamination control.
Laboratory Operations
- Perform microbial enumeration, isolation, and identification of bacteria, yeast, and mold.
- Conduct microbiological testing of purified water, raw materials, and environmental samples.
- Manage sample tracking, testing schedules, and data integrity for all microbiological analyses.
- Oversee safe handling and disposal of biohazardous materials.
Quality and Compliance
- Author, review, and update microbiology-related SOPs, work instructions, and protocols.
- Ensure all microbiology activities comply with GMP, ISO 13485, and internal quality system requirements.
- Participate in supplier qualification, including audits of contract labs and material suppliers.
- Interface with external labs for outsourced testing and oversee data review and release.
Laboratory Development
- Lead the design and qualification of an in-house microbiology lab to transition testing from external to internal control.
- Define test capabilities, select equipment, and develop procedures for microbiological testing.
- Support validation of new methods and qualification of analytical equipment.
Education:
- University degree in microbiology, or related science discipline with evidence of completion of microbiology courses
Experience:
- 3 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.
We thank all applicants for their interest, however, only those selected for further consideration will be contacted.
Skills Required
- University degree in microbiology or related science with microbiology coursework
- Minimum 3 years practical experience as a Microbiologist in commercial, laboratory, or research setting
- Experience working under a quality management system (pharmaceutical or medical device)
- Working knowledge of aseptic techniques, environmental monitoring methods, and contamination control
- Experience with laboratory apparatus, equipment, and safe handling/disposal of biohazardous materials
- Ability to perform microbial enumeration, isolation, and identification of bacteria, yeast, and mold
- Ability to prepare, interpret, and generate routine test reports in accordance with regulatory and internal guidelines
- Clear and fluent oral and written communication in English
- Ability to work as part of a team and with minimum supervision, and to take initiative to improve processes
What We Do
University Health Network is Canada's largest research hospital and a public research and teaching hospital network in Toronto, Ontario, known for its scope of research and complexity of cases.
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