Environmental Monitoring Compliance Associate

Maintain a robust environmental monitoring (EM) program for all classified areas to ensure that sterile products meet internal quality standards and those of regulatory agencies (e.g., Health Canada, FDA, EU). Ensure compliance with personnel qualification and environmental monitoring protocols, and serve as a subject matter expert (SME) in environmental control and aseptic processes. Participate in drafting microbiology department investigations.

Key Responsibilities

• Regulatory Compliance: Review and revise environmental monitoring programs to align with current regulatory and industry standards for sterile manufacturing.
• Facility Audits: Conduct regular audits of classified cleanroom areas to ensure adherence to environmental and procedural standards.
• Continuous Education: Stay current with emerging EM-related regulations and attend relevant training sessions and conferences.
• Program Requalification: Participate in periodic requalification of the environmental monitoring program.
• Subject Matter Expertise: Serve as an SME for environmental controls and aseptic processing.
• Trend Analysis: Produce environmental monitoring trend reports and oversee corrective actions to maintain compliance in controlled environments.
• Risk Assessments: Perform risk evaluations related to EM and develop performance qualification protocols and documentation.
  
  

: Minimum B.Sc. in Microbiology or a closely related field, or an equivalent combination of education and experience. Experience: At least 5 years of experience in microbiology and environmental monitoring in a pharmaceutical or healthcare manufacturing environment.

Required Skills

• In-depth understanding of pharmaceutical manufacturing and processing techniques.
• Strong grasp of validation, manufacturing, packaging, and testing workflows.
• Familiarity with current Good Manufacturing Practices (cGMP) in Canada, the U.S., and the EU.
• Proficiency in Microsoft Office and SAP systems.
• Exceptional attention to detail and methodical work habits.
• Strong interpersonal, organizational, communication, and problem-solving skills.
• Capability to make sound decisions under pressure.
  
  

If you would like to learn more about this fantastic opportunity, please email and reference job# 19352.