QC Senior Microbiologist

WHAT WE ARE LOOKING FOR

The QC Senior Microbiologist will operate 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.

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)
• Evaluate EM data for adverse trends and implement corrective/preventive actions (CAPAs)
• Perform root cause analysis using established investigation tools and methodologies
• 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