Job Title: Microbiology / Contamination Control Strategy (CCS) SME
Industry: Pharmaceutical / Biotechnology
Job Type: Contract
Location: Greater Toronto Area (GTA), Ontario, Canada
Work Arrangement: On-site
Experience: 10+ Years
Duration: 12+ Months, with possible extension
Job Summary:
We are seeking an experienced Microbiology / Contamination Control Strategy (CCS) SME to support microbiological quality systems and contamination control activities at pharmaceutical manufacturing and packaging facilities. The candidate will be responsible for developing and improving the site's Contamination Control Strategy, strengthening environmental monitoring programs, and ensuring compliance with applicable GMP and regulatory requirements.
The role will focus on non-sterile solid oral dosage manufacturing and packaging operations, microbiological investigations, pharmaceutical water system monitoring, and microbiology laboratory inspection readiness. The successful candidate will work closely with Quality Assurance, Quality Control, Manufacturing, and Facilities teams to identify contamination risks, implement corrective actions, and maintain effective microbiological controls.
Key Responsibilities:
Contamination Control Strategy: Develop, review, and improve the site's Contamination Control Strategy (CCS) for non-sterile pharmaceutical manufacturing and packaging operations.
Environmental Monitoring: Review and strengthen environmental monitoring programs, including sampling plans, alert and action limits, microbiological testing, and data trending.
Microbiological Risk Assessment: Conduct risk assessments for objectionable microorganisms in non-sterile pharmaceutical products and recommend appropriate contamination prevention measures.
Microbiological Investigations: Investigate and review microbiological deviations, environmental monitoring excursions, and contamination-related events. Identify root causes and support the implementation of corrective and preventive actions (CAPA).
Pharmaceutical Water Systems: Review microbiological monitoring programs for pharmaceutical water systems and assess contamination control measures and disinfectant efficacy studies.
Laboratory Inspection Readiness: Prepare microbiology laboratories for Health Canada and FDA inspections by reviewing procedures, laboratory practices, technical documentation, and quality records.
Regulatory Compliance: Ensure microbiology and contamination control activities comply with applicable GMP requirements, regulatory guidelines, and relevant USP standards.
Quality Documentation: Prepare, review, and maintain CCS documents, microbiological investigation reports, risk assessments, environmental monitoring reports, and other quality records.
Training and Development: Train site personnel on contamination prevention, hygiene practices, microbiological controls, and relevant GMP requirements.
Cross-Functional Collaboration: Work with QA, QC Microbiology, Manufacturing, and Facilities teams to identify contamination risks and implement sustainable quality improvements.
Continuous Improvement: Identify gaps in microbiological quality systems and recommend improvements to environmental monitoring, contamination prevention, and laboratory compliance processes.
Required Skills:
- Minimum 10+ years of experience in pharmaceutical microbiology, environmental monitoring, and contamination control.
- Demonstrated experience developing, reviewing, or remediating a Contamination Control Strategy (CCS).
- Strong knowledge of microbiological testing and quality control in pharmaceutical manufacturing.
- Hands-on experience with environmental monitoring programs, microbiological investigations, and contamination-related deviations.
- Experience with root cause analysis, CAPA, and microbiological data trending.
- Knowledge of pharmaceutical water system monitoring and contamination prevention practices.
- Familiarity with USP chapters 61, 62, 1111, and 1115.
- Strong understanding of Health Canada GMP requirements and FDA 21 CFR Parts 210, 211, and 11.
- Knowledge of Health Canada Food and Drug Regulations, Part C, Division 2, and GMP Guide GUI-0001.
- Familiarity with ICH Q7, Q9, and Q10 and relevant PIC/S GMP guidance.
- Strong technical writing, investigation, documentation, and problem-solving skills.
- Ability to independently prepare, review, and close technical documents and quality records.
- Excellent written and verbal communication skills.
- Must be legally authorized to work in Canada and available to work on-site in the Greater Toronto Area.
- Willingness to complete background checks and required site-access training.
