QC Senior Microbiologist

Guerbet; Raleigh (NC); On-site; USD 110,000 - 160,000; Full time

Job summary

Guerbet seeks a QC Senior Microbiologist to lead microbiological quality systems in an aseptic pharmaceutical manufacturing facility. You will oversee sterile processes, environmental monitoring, trend analysis, investigations, and CAPA execution to ensure cGMP compliance and data integrity.

You will provide technical guidance to junior microbiologists and manufacturing staff, collaborate with QA, and support contamination control strategies while maintaining robust documentation and regulatory

Qualifications

• Bachelor’s degree in Microbiology, Biology, or related life science.
• Minimum of 5–8 years of microbiology experience in pharma/biotech aseptic manufacturing.
• Demonstrated experience supporting aseptic processing/terminal sterilization cleanroom operations.

Responsibilities

• Provide microbiological oversight of aseptic manufacturing processes, including cleanroom operations.
• Support sterility assurance programs, ensuring regulatory expectations are met.
• Review and approve environmental monitoring 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 and trend analysis.
• Perform root cause analysis and implement CAPAs for investigations.
• Oversee method validation, verification, and suitability activities.
• Serve as SME for microbiological and aseptic processing topics.

Skills

Microbiology

Environmental Monitoring

CAPA investigations

Data interpretation

GMP compliance

Education

Bachelor’s degree in Microbiology

Master’s degree in Microbiology

Job description

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.
We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 100 years, we continuously innovate to improve the diagnosis, prognosis and quality of life of patients.
Customer Centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice on a daily basis.
Working at Guerbet is not only being part of a multicultural team with nearly 3,000 people across more than 20 countries, but it is above all about playing a unique role in the future of medical imaging.

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