Pharmaceutical Solution Process Engineer

Responsibilities

• Design and develop pharmaceutical manufacturing processes, including equipment selection, process flow, and operational parameters
• Ensure strict compliance with cGMP regulations, FDA guidelines, and industry standards throughout process design
• Plan and schedule manufacturing activities to meet production targets while optimizing resource utilization
• Monitor manufacturing processes to ensure product quality, consistency, and regulatory compliance
• Conduct process troubleshooting and root cause analysis for deviations, non-conformances, and quality issues
• Implement continuous improvement initiatives using Lean manufacturing and Six Sigma methodologies
• Investigate quality incidents and implement corrective and preventive actions (CAPA)
• Collaborate with Quality Assurance and Quality Control departments to support audits and inspections
• Maintain accurate production records, batch documentation, and inventory control records
• Train manufacturing personnel on standard operating procedures (SOPs) and safety protocols

Requirements

• Bachelor's or master's degree in chemical engineering, biotechnology engineering, or a related field
• Minimum of 2 years of experience in pharmaceutical manufacturing
• Thorough understanding of cGMP regulations and FDA guidelines
• Strong problem-solving abilities and attention to detail
• Excellent communication and interpersonal skills for cross-departmental collaboration

Preferred Qualifications

• Knowledge of Microbiological evaluation methods
• Experience with Lean manufacturing or Six Sigma methodologies
• Proficiency in MS Office and Manufacturing Execution Systems (MES)

About the Company

Traferox creates, manufactures, and commercializes products used to transplant solid organs such as lungs, hearts, livers, kidneys, and pancreases. Utilizing technologies invented by transplant surgeons at the University Health Network (UHN), Traferox is committed to improving organ transplant outcomes and saving patients' lives.