QC Senior Microbiologist
Laboratoire Guerbet
Summary
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.
Job description
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
Requirements
- 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
- Experience conducting assays including bioburden, bacterial endotoxin testing, sterility testing, growth promoting testing, and basic bacterial staining techniques
- Experience with Environmental Monitoring (cleanrooms, water systems, compressed gases)
- Demonstrated experience supporting aseptic processing/terminal sterilization cleanroom operations
- Master's degree in Microbiology or a related life science (preferred)
- Experience supporting or participating in regulatory inspections (e.g., FDA, EMA, or equivalent) (preferred)
- Capable of interpreting the microbiology, sterility assurance, and contamination control aspects of EU, PIC/S Annex I (preferred)
Company overview
Laboratoire Guerbet, also known as Guerbet Group, is a pioneering French pharmaceutical company that has been at the forefront of medical imaging since its official establishment in 1926. The company traces its origins to 1901 when Marcel Guerbet discovered the world's first iodinated contrast medium, Lipiodol. Today, Guerbet specializes in developing and manufacturing contrast media, injection systems, medical devices, and digital solutions for diagnostic and interventional imaging. With a workforce of over 2,900 employees globally, the company operates manufacturing facilities across France, Brazil, Ireland, and the United States. Guerbet's comprehensive product portfolio includes MRI contrast agents like Dotarem and Elucirem, X-ray contrast media, and specialized solutions for interventional radiology. The company has achieved global leadership in medical imaging, ranking among the world's top three players in the sector following its strategic acquisition of Mallinckrodt's contrast media business in 2015. Guerbet continues to innovate through investments in digital technologies and artificial intelligence, aiming to improve radiologist productivity and enhance tumor characterization for better treatment guidance.