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.
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 person