Pharmaceutical Solution Process Engineer bei University Health Network

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.

Department: Manufacturing

Site: 3505 Laird Road, Mississauga, Ontario

Reports to: Pharmaceutical Solution Process Engineer and Manufacturing Supervisor

Hours: 37.5 hours per week

Status: Permanent Full-time

Closing Date: September 22nd, 2025

Duties and Responsibilities:

• Design and develop pharmaceutical manufacturing processes, including equipment selection, process flow, and operational parameters.
• Ensure compliance with regulatory guidelines, industry standards, and Good Manufacturing Practices (GMP) throughout process design and development.
• Plan and schedule manufacturing activities to meet production targets while optimizing resource utilization and minimizing downtime.
• Monitor manufacturing processes closely to ensure product quality, consistency, and compliance with regulatory requirements.
• Continuously evaluate and improve existing manufacturing processes to enhance efficiency, yield, and product quality.
• Conduct process troubleshooting and root cause analysis for deviations, non-conformances, and quality issues.
• Identify and implement process improvements, such as equipment modifications, automation, or procedural changes, to optimize production and reduce costs.
• Train manufacturing personnel on standard operating procedures (SOPs), safety protocols, and best practices to enhance team performance and skills development.
• Conduct regular inspections of manufacturing equipment and facilities to ensure proper operation, cleanliness, and maintenance.
• Investigate deviations, non-conformances, and quality incidents, implementing corrective and preventive actions as necessary to address root causes and prevent recurrence.
• Collaborate with Quality Assurance and Quality Control departments to support investigations, audits, and inspections, providing relevant documentation and technical expertise.
• Implement continuous improvement initiatives to enhance manufacturing processes, efficiency, and product quality, utilizing tools such as Lean manufacturing and Six Sigma methodologies.
• Ensure compliance with environmental, health, and safety regulations in all manufacturing activities, promoting a culture of safety and environmental stewardship.
• Maintain accurate production records, batch documentation, and inventory control records in compliance with regulatory requirements and company policies.

Education:

• Bachelor's or master’s degree in chemical or biotechnology engineering, or a related field.

Experience:

• Minimum of 2 years of experience in pharmaceutical manufacturing. Knowledge of Microbiological evaluation methods is very beneficial.

Skills and Knowledge:

• Thorough understanding of cGMP regulations, FDA guidelines, and industry best practices related to pharmaceutical manufacturing.
• Strong leadership skills, with the ability to motivate and develop a diverse workforce.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across departments and levels of the organization.
• Demonstrated problem-solving abilities and a proactive approach to addressing manufacturing challenges and process improvements.
• Experience with Lean manufacturing, Six Sigma, or other continuous improvement methodologies is desirable.
• Proficiency in computer applications such as MS Office and manufacturing execution systems (MES) is preferred.
• Flexibility to work in a fast-paced environment and adapt to changing priorities and business needs.
• Strong attention to detail, organizational skills, and a commitment to upholding the highest standards of product quality and regulatory compliance.