QC Senior Microbiologist

WHAT WE ARE LOOKING FOR

The QC Senior Microbiologist will be operating in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for.

The QC Senior Microbiologist is responsible for providing technical leadership and oversight for microbiological quality systems within an aseptic pharmaceutical manufacturing facility. This role supports sterility assurance programs, environmental monitoring, contamination investigations, and microbiological method execution in compliance with current Good Manufacturing Practices (cGMP), regulatory expectations, and internal quality standards.

YOUR ROLE

• Provide microbiological oversight of aseptic manufacturing processes, including cleanroom operations, aseptic filling, and compounding activities
• Support sterility assurance programs, ensuring compliance with regulatory expectations
• Review and approve environmental monitoring (EM) data and trends for classified areas (ISO 5–8)
• Ensure viable and non-viable monitoring strategies are appropriate for aseptic conditions
• Lead environmental monitoring programs, including routine sampling, excursion response, and data trending
• Evaluate EM data for adverse trends and implement corrective/preventive actions (CAPAs)
• Maintain alert and action limit systems aligned with historical data and regulatory expectations
• Author periodic microbiological trend reports for quality review
• Lead microbiological investigations related to out-of-specification (OOS), out-of-trend (OOT), sterility failures, and contamination events
• Perform root cause analysis using established investigation tools and methodologies
• Provide scientifically sound conclusions and recommendations to prevent recurrence
• Support contamination control strategy (CCS) development and continuous improvement
• Ensure laboratory activities comply with cGMP, data integrity principles, and GDP (Good Documentation Practices)
• Oversee method validation, verification, and suitability activities
• Serve as subject matter expert (SME) for microbiological and aseptic processing topics
• Provide technical guidance and training to junior microbiologists and manufacturing personnel

YOUR BACKGROUND

Required Qualifications

• Bachelor’s degree in Microbiology, Biology, or a related life science
• Minimum of 5–8 years of microbiology experience in a pharmaceutical, biotechnology, or aseptic/terminal sterilization manufacturing environment conducting assays including, but not limited to: bioburden, bacterial endotoxin testing, sterility testing, growth promoting testing, basic bacterial staining techniques (e.g. gram. spore), Environmental Monitoring (cleanrooms, water systems, compressed gases).
• Demonstrated experience supporting aseptic processing/terminal sterilization cleanroom operations

Preferred Qualifications

• Master’s degree in Microbiology or a related life science
• Experience supporting or participating in regulatory inspections (e.g., FDA, EMA, or equivalent)
• Capable of interpreting the microbiology, sterility assurance, and contamination control aspects of EU,PIC/S Annex I