Aseptic Filling Specialist

Responsibilities

• Operate aseptic filling equipment to ensure accurate and sterile filling of products
• Perform routine cleaning and sanitization of equipment and work areas to maintain cleanroom standards
• Conduct in-process checks and environmental monitoring
• Troubleshoot and resolve technical issues with aseptic filling equipment
• Record and maintain accurate production documentation, including batch records and logbooks
• Follow strict safety protocols to prevent contamination and ensure personnel safety
• Perform process troubleshooting and root cause analysis for buffer solution manufacturing
• Participate in validation and qualification activities (IQ, OQ, PQ) for manufacturing processes and equipment
• Identify opportunities for process optimization, innovation, and cost reduction
• Assist with inventory management, vendor relations, and order placements

Requirements

• Undergraduate degree in Chemical Engineering, Pharmaceutical Sciences, Microbiology, Biotechnology, Chemistry, or Biochemistry
• 2-3 years of experience in aseptic filling, sterile manufacturing, or a related pharmaceutical manufacturing role
• Proven experience with cleanroom gowning and aseptic techniques
• Strong knowledge of GMP and regulatory compliance (FDA, EMA)
• Ability to work in a sterile, controlled cleanroom environment and stand for extended periods
• Ability to lift and carry materials up to 20 lbs and handle sensitive equipment
• Excellent analytical, problem-solving, and attention-to-detail skills

Preferred Qualifications

• Proficiency in statistical analysis and experimental design (e.g., Design of Experiments)

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.