REQUIRED QUALIFICATIONS & EXPERIENCE:

• Degree in Microbiology, Life Sciences, or a closely related discipline, or equivalent practical experience in the field.
• A minimum of 5 years’ hands-on experience with EM practices and microbiological testing in pharmaceutical or regulated healthcare environments.
• Solid knowledge of pharmaceutical production, including equipment validation, quality control, packaging, and manufacturing workflows.
• Comprehensive understanding of cGMP requirements as outlined by Canadian, U.S., and EU regulatory bodies.
• Strong interpersonal and communication skills, with the ability to work cross-functionally.
• Proven expertise in sterile manufacturing and regulatory-compliant operational practices.
  Job Type: Full-time

Schedule:

• Monday to Friday

Work Location: In perso

ROLE SUMMARY:

Lead and maintain a robust environmental monitoring (EM) program to support regulatory adherence and ensure environmental control in manufacturing operations.

KEY RESPONSIBILITIES:

• Manage the ongoing execution of the EM program, ensuring alignment with current regulatory standards.
• Review and revise EM protocols regularly to incorporate regulatory updates and industry innovations.
• Perform regular walkthroughs and inspections within classified areas to confirm compliance with SOPs and applicable regulatory frameworks.
• Monitor and interpret emerging changes in EM regulations and industry guidance.
• Support EM system requalification efforts to sustain validated manufacturing conditions.
• Offer technical support and advice on aseptic operations and contamination control strategies.
• Track and evaluate EM data trends to drive improvements and maintain a state of control.
• Conduct risk assessments for EM-related processes and document performance against validation criteria.