Pharma Microbiologist – GMP Environmental Monitoring

AstraZeneca; Hamilton; On-site; CAD 68,000 - 89,000; Full time

Job summary

Fusion Pharmaceuticals, a member of the AstraZeneca Group, is seeking a Microbiologist to provide SME leadership in environmental monitoring, contamination control, and cleanroom process design within a regulated pharmaceutical manufacturing environment in Hamilton, Ontario.

The role focuses on developing and maintaining microbiological control strategies to meet EU Annex 1, GMP, and health authority expectations, authoring procedures, guiding bioburden control, and supporting investigations and

Qualifications

• Minimum bachelor's degree in microbiology or related discipline.
• 5+ years in pharmaceutical microbiology within GMP cleanrooms.
• Experience with EU Annex 1 and cGMP regulatory requirements.

Responsibilities

• Contamination Control and Environmental Monitoring: Provide SME support for contamination control and environmental monitoring in pharmaceutical manufacturing.
• Program Ownership: Design, implement, maintain, and improve the site environmental monitoring program for classified manufacturing areas, including viable and particulate monitoring, sampling plans, alert/action levels, data review, and trending.
• Trend and Excursion Assessment: Interpret environmental monitoring trends, assess excursions and out-of-limit results, and evaluate microbiological risks to product, process, and facility control.
• EMPQ Leadership: Lead and support EMPQ activities for new and existing cleanrooms, equipment, utilities, and processes, ensuring sound study design, execution, documentation, and interpretation.
• Investigations and CAPA: Lead or support investigations related to environmental excursions, contamination events, atypical results, utility monitoring failures, and process deviations, including root cause analysis and CAPA.
• Bioburden Oversight: Provide technical guidance on bioburden control strategies, routine monitoring, sampling rationale, method suitability, and data interpretation.
• Documentation and Compliance: Author and revise GMP procedures and technical documents, while ensuring microbiological programs remain compliant and inspection ready.
• Change Control and Risk Assessment: Provide microbiological input into change controls, risk assessments, and qualification activities involving facilities, utilities, equipment, materials, and manufacturing processes.
• Training and Cross-Functional Support: Deliver technical coaching and training to operations, quality, and support teams, and influence site practices through scientific, risk-based decision-making.
• Cleanroom Qualification and Sampling Plans: Support cleanroom qualification and requalification activities and develop scientifically justified environmental and bioburden sampling plans.

Skills

Environmental Monitoring

Contamination Control

Cleanroom Operations

Regulatory Compliance

Technical leadership

Education

Bachelor's degree in microbiology or related field

Job description

Fusion Pharmaceuticals, a member of the AstraZeneca Group, is seeking a Microbiologist to provide SME leadership in environmental monitoring, contamination control, and cleanroom process design within a regulated pharmaceutical manufacturing environment in Hamilton, Ontario.

The role focuses on developing and maintaining microbiological control strategies to meet EU Annex 1, GMP, and health authority expectations, authoring procedures, guiding bioburden control, and supporting investigations and