QC Senior Microbiologist (Raleigh, US)

Guerbet; Raleigh (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Guerbet, a global leader in medical imaging, is seeking a QC Senior Microbiologist to provide technical leadership for microbiological quality systems within an aseptic pharmaceutical manufacturing facility. You will support sterility assurance, environmental monitoring, and contamination investigations in compliance with cGMP and GDP.

The role requires overseeing EM data, CAPAs, method validation support, and training junior staff.

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 manufacturing environment.
• 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.
• 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, 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 OOS, 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.

Skills

cGMP knowledge

Environmental Monitoring

Sterility testing

Aseptic processing

Root cause analysis

Education

Bachelor's degree in Microbiology or related life science

Master’s degree in Microbiology or related life science

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 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

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

Reason to join US

Much more than a Competitive salary,

We offer continued personal development. When you join Guerbet, you :

• Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,
• Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world,
• Are joining a company where we value diversity of talents coming from various horizon.

We # Innovate # Cooperate # Care #Achieve at Guerbet.

Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.

Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to [e-mail] or you can also call this number [phone]