Microbiologist

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.

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.

• Union:
  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

• 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).

• 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.

• 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.

• 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.

• 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.

• University degree in…