Senior Microbiologist, Aseptic QC & Sterility Lead

Guerbet; Raleigh (NC); In loco; USD 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

cGMP knowledge

Environmental Monitoring

Sterility testing

Aseptic processing

Root cause analysis

Formazione

Bachelor's degree in Microbiology or related life science

Master’s degree in Microbiology or related life science

Descrizione del lavoro

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.