Aseptic Filling Specialist

1 day ago

Laird Rd Mississauga ON LL Y Canada Traferox Technologies Full time US$72,000 - US$90,000 per year
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

Work Location: 3505 Laird Road, Mississauga

Department: Manufacturing

Reports to: Pharmaceutical Solution Manufacturing Supervisor

Work Model: On-site

Status: Permanent Full-time

Closing date: December 17, 2025

Duties and Responsibilities: 

  • Operate aseptic filling equipment to ensure accurate and sterile filling of products.
  • Perform routine cleaning and sanitization of equipment and work area to maintain a cleanroom environment.
  • Conduct in-process checks and environmental monitoring.
  • Troubleshoot and resolve technical issues with aseptic filling equipment.
  • Record and maintain accurate documentation of the production process, including batch records and logbooks.
  • Follow safety protocols to prevent contamination and ensure the safety of all personnel in the aseptic environment
  • Assist with inventory managements / vendor relations / order placements.
  • Perform process troubleshooting and root cause analysis specific to buffer solution manufacturing and aseptic filling, addressing deviations and ensuring continuous improvement.
  • Participate in validation and qualification activities for manufacturing processes, equipment, and facilities, in accordance with regulatory requirements and company guidelines.
  • Assist in developing and execution of validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Identify opportunities for process optimization, innovation, and cost reduction.
  • Must be able to work in a sterile, controlled cleanroom environment. 
  • Performs all other job-related duties as assigned.
Qualifications
  • Undergraduate degree in chemical process engineering, pharmaceutical Sciences, Microbiology, Biotechnology, chemistry, biochemistry or related field.
  • Minimum of 2-3 years of experience in aseptic filling, sterile manufacturing, or a related role in a laboratory or pharmaceutical manufacturing.
  • Experience with cleanroom gowning and aseptic techniques. 
  • Strong interpersonal and communication skills with the ability to work independently and collaborate effectively with cross functional teams.
  • Excellent analytical and problem-solving skills, with a keen attention to detail.
  • Knowledge of aseptic processing, GMP, and regulatory compliance (FDA, EMA).
  • Proficiency in statistical analysis and experimental design (e.g., Design of Experiments) is beneficial but not mandatory.
  • Ability to work in a sterile, controlled cleanroom environment. Comfortable with standing for extended periods.
  • Ability to lift and carry materials up to 20 lbs and handle sensitive equipment. 

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