Microbiologist, Sterility Assurance

Job Summary

The Microbiologist, Sterility Assurance will be responsible for performing environmental monitoring, clean utilities monitoring and other sterility assurance activities within the Apotex group of companies. The incumbent is responsible for generating accurate results while following GMP requirements in accordance with established compendial and in-house procedures.  

Job Responsibilities

• Ensure collection of environmental monitoring and clean utilities samples according to the sampling schedule.
• Displays a strong understanding of aseptic techniques and proficiency in environmental monitoring and clean utilities monitoring.
• Good understanding of compendial requirements pertaining to monitoring activities.
• Coordinates and monitor inventory of environmental monitoring and clean utilities monitoring supplies.
• Operate and maintain equipment and instruments.
• Assists in the execution of sterility assurance and sterile validation protocols
  • Aseptic Process Simulations (Media Fill)
  • Environmental Monitoring Qualification
  • Clean Utilities Qualification
  • Airflow Visualization Studies (Smoke Studies)
  • Thermal (Moist / Dry Heat) and Gaseous (VHP / ETO) Validation
  • VHP Ingress Studies and other Environmental Monitoring Studies (i.e. Clean Hold Time and HVAC Recovery)
• Works collaboratively with team members to troubleshoot obstacles.
• Demonstrates a good working knowledge of LIMS and SAP as required.
• Accountable to maintain compliance with assigned training plan pertinent to the job function.
• Escalate any safety related issue to management in a timely manner.
• Promotes a positive work environment and be a good team player.
• Ensures that all work is performed in compliance with current Good Manufacturing Practices, Good Laboratory Practices, Standard Operating Procedures, established safety standards, compendial and other regulatory requirements.
• Performs all work in support of our Corporate Values.
• All other duties as assigned

Job Requirements

• Education
  • Minimum Diploma in Microbiology or similar qualification in closely related field 
  • B.Sc in Biology / Microbiology / Applied Pharmaceutical Sciences is preferred
• Knowledge, Skills and Abilities
  • Strong knowledge of microbiological techniques including aseptic technique
  • Proficiency in Microsoft Word and Excel; prior experience with LIMS would be an asset.
  • Able to work independently with minimal supervision.
  • Good verbal and written communication and interpersonal skills.
  • Detail oriented with excellent problem solving skills.
  • Strong understanding and utilization of GMP and GLP.
  • Proven organizational and time management skills, as demonstrated through previous work and/or experience.
  • Role will require repetitive, routine environmental monitoring and clean utilities monitoring activities. In addition, job will require work inside a manufacturing area or mechanical room for sample collection.
  • Role will involve weekend coverage.
• Experience
  • Minimum 1-2 years of experience in a GMP production environment, sterile manufacturing experience is an asset.