Environmental Monitoring Compliance Associate

(onsite in Montreal)Responsibilities

• Maintain a robust environmental monitoring (EM) program for all classified areas to ensure that all sterile products manufactured meet the internal standards of company and those of regulatory agencies (Health Canada, FDA, EU, etc.).
• Ensure compliance of the personnel qualification and environmental monitoring programs. Serve as a subject matter expert (SME) for environmental control and aseptic processes. Participate in the drafting of investigations for the microbiology department.

Key Responsibilities

• Review regulatory standards concerning sterile manufacturing environmental monitoring programs and revise the existing program to develop and implement a solid and compliant EM program according to regulatory and industry standards.
• Perform regular audits of classified areas to ensure compliance with standards and procedures.
• Stay informed on emerging standards or regulations related to EM and attend relevant training conferences.
• Participate in the requalification process of the EM program.
• Serve as a subject matter expert for environmental control and aseptic processes.
• Generate EM trend reports and ensure follow-up corrective actions are taken to maintain controlled classified environments.
• Perform risk assessments related to EM and document performance qualification protocols and reports.

External:

• Regulatory agencies
• Clients
• Suppliers

Internal:

• Operations
• Quality
• Engineering

Required Education

• Minimum B.Sc. in Microbiology, or an equivalent combination of education and experience.

Required Experience:

• Five (5) years of experience in microbiology and environmental monitoring within a pharmaceutical or healthcare manufacturing environment.

Required Skills:

• Good knowledge of pharmaceutical processing techniques.
• Strong understanding of validation, manufacturing, packaging, and testing processes in the pharmaceutical industry.
• Excellent knowledge of cGMP regulations for Canada, the U.S., and Europe.
• Proficiency with Microsoft Office and SAP environment.
• Attention to detail, precision, and methodical work habits.
• Strong interpersonal, communication, organizational, and problem-solving skills.
• Strong decision-making abilities under stressful conditions.

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