Pharmaceutical Solution Process Engineer

4h4 hours ago

University Health Network

Mississauga, CA · Full-time · C$75,000 – C$90,000

About this role

Traferox, a UHN-affiliated company, creates and commercializes products used to transplant solid organs, including the TorEx Lung Perfusion System and XPort Lung Transport Device. As a Pharmaceutical Solution Process Engineer, you will design and develop pharmaceutical manufacturing processes, selecting equipment and defining operational parameters to support life-saving organ transplant technologies.

In this role, you will plan and schedule manufacturing activities to meet production targets while optimizing resource utilization and minimizing downtime. You will monitor manufacturing processes closely to ensure product quality, consistency, and compliance with regulatory requirements, and conduct process troubleshooting and root cause analysis for deviations and quality issues.

You will collaborate with Quality Assurance and Quality Control departments to support investigations, audits, and inspections, providing relevant documentation and technical expertise. The team is committed to improving organ transplant outcomes and saving patients' lives, working in a GMP-regulated environment at the Mississauga site.

This permanent full-time position offers the opportunity to implement continuous improvement initiatives using Lean manufacturing and Six Sigma methodologies. You will train manufacturing personnel on SOPs and best practices, contributing to a culture of safety and environmental stewardship while advancing your career in pharmaceutical engineering.

Requirements

Bachelor's or master's degree in chemical or biotechnology engineering, or a related field.
Minimum of 2 years of experience in pharmaceutical manufacturing.
Thorough understanding of cGMP regulations, FDA guidelines, and industry best practices related to pharmaceutical manufacturing.
Knowledge of microbiological evaluation methods is very beneficial.
Strong leadership skills, with the ability to motivate and develop a team.
Experience with process troubleshooting and root cause analysis for deviations and quality issues.
Ability to maintain accurate production records, batch documentation, and inventory control records in compliance with regulatory requirements.

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.
Conduct process troubleshooting and root cause analysis for deviations, non-conformances, and quality issues.
Train manufacturing personnel on standard operating procedures (SOPs), safety protocols, and best practices to enhance team performance.
Collaborate with Quality Assurance and Quality Control departments to support investigations, audits, and inspections.
Implement continuous improvement initiatives to enhance manufacturing processes, efficiency, and product quality, utilizing Lean manufacturing and Six Sigma methodologies.

Benefits

Annual wage range of $75,000 - $90,000.
Permanent full-time position with 37.5 hours per week.
Opportunity to work on life-saving organ transplant technologies.
Non-union role with direct reporting to the Pharmaceutical Solution Manufacturing Supervisor.