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

We are hiring a Sterile Manufacturing Equipment Maintenance & Validation Engineer to own hands-on technical support for aseptic fill-finish operations (bottle filling and IV bag filling) and to lead execution of cleanroom routine maintenance and validation/requalification activities. You will drive equipment reliability, reduce downtime, and maintain a strong state of control in a regulated environment.

What you will do:

Aseptic processing equipment ownership

• Troubleshoot, repair, and maintain complex aseptic filling equipment for bottles and IV bags (mechanical, electrical, pneumatic, instrumentation, and controls).
• Diagnose faults using drawings/schematics, OEM documentation, alarms, trending, and systematic root-cause methods.
• Own PM strategy and execution: PM plans, job plans, lubrication/inspection standards, calibration coordination, and critical spares.
• Lead reliability improvements: repeat-failure elimination, downtime tracking, and corrective action effectiveness checks.
• Coordinate OEM/vendor service and support: scope work, supervise execution, and verify outcomes.

Cleanroom maintenance and validation/requalification

• Execute and maintain the site plan for cleanroom routine maintenance and periodic requalification activities in support of aseptic operations.
• Lead qualification/validation deliverables tied to equipment and controlled environments (IQ/OQ/PQ execution support, protocols, reports, and traceable evidence).
• Support change control impact assessments for equipment, components, recipes/settings, and maintenance changes.
• Coordinate and support cleanroom certification activities (e.g., HEPA integrity testing, airflow visualization, particle mapping, pressure differential verification) and maintain documentation packages.

Quality and compliance

• Support deviations, investigations, and CAPAs with strong root-cause analysis and clear technical documentation.
• Update and create SOPs/work instructions for maintenance, setup checks, and controlled-environment activities.
• Support internal and external audits/inspections by providing objective evidence and technical explanations.

Qualifications

• 5+ years in a regulated manufacturing environment (pharma/biotech/medical device preferred), supporting complex production equipment.
• Demonstrated hands-on troubleshooting across mechanical, electrical, and controls domains.
• Experience executing qualification/validation work (not only reviewing), including protocol execution and report writing.
• Strong documentation practices and comfort working under GMP expectations.
• Willingness to work in cleanrooms and support planned shutdown windows; ability to support on-call or off-shift work as needed.

Preferred qualifications:

• Experience in aseptic fill-finish equipment (bottle filling, IV bag filling, sterile transfer systems, RABS/isolators).
• Exposure to PLC/HMI troubleshooting, instrumentation, and sensor tuning.
• Experience coordinating cleanroom certification providers and interpreting results/trends.

What success looks like:

• Reduced unplanned downtime and repeat failures on aseptic filling lines.
• Clear, practical PM system with high schedule compliance and effective spare parts strategy.
• Cleanroom and equipment qualification activities executed on time with complete, audit-ready documentation.
• Fast, structured response to issues with strong root-cause and durable fixes.

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.