Sterility Assurance Lead

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 FORUnder the direction of the Site Quality Manager, the Sterility Assurance Lead supports the site’s sterility assurance activities to ensure compliance with regulatory requirements, including EU Annex 1. This role assists with aseptic processing standards, bioburden control, cleanroom behavior and monitoring, and provides day‑to‑day sterility assurance support for sterile manufacturing operations.The position contributes to a culture of quality, risk management, and continuous improvement in sterile product manufacturing. The role includes assisting with microbiological data review, participating in issue identification and remediation, and working with operations and quality teams to resolve product quality concerns.The Sterility Assurance Lead also collaborates with Microbiology personnel to help ensure test methods, procedures, and documentation meet approved SOPs and regulatory expectations.YOUR ROLESupport site sterility assurance activities under the direction of the Site Quality Manager. Assist with tasks related to Annex 1 compliance and contamination control, including participating in contamination control strategy activities, routine assessments, and documentation updates.Assist with aseptic processing standards, pre‑autoclave bioburden checks, cleanroom behavior monitoring, and day‑to‑day sterility assurance support during sterile manufacturing operations. Participate in routine reviews of environmental and personnel monitoring data, support investigations, and help ensure timely responses to excursions.Support risk assessments for aseptic processes and take part in the execution, documentation, and review of aseptic simulation (media fill) activities. Participate in smoke studies or airflow visualization assessments as directed. Assist with evaluating gowning practices, personnel behaviors, and aseptic techniques.Perform real‑time review of relevant logs, records, and QC test results for completeness, accuracy, and compliance with SOPs. Assist with deviation investigations, CAPA documentation, and change control activities related to sterile operations.Support basic sterility assurance training, aseptic behavior coaching, and contamination control awareness for operations personnel. Work closely with Microbiology and QC teams to ensure test methods, procedures, and documentation meet SOP and regulatory expectations.Participate in internal audits and inspection readiness activities related to aseptic practices. Assist in identifying compliance gaps and support corrective actions under the guidance of senior sterility assurance or quality leadership.Maintain a strong focus on safe work practices and timely escalation of potential risks or issues.YOUR BACKGROUNDStrong interpersonal and communication skills.Knowledge of aseptic processing fundamentals, cleanroom behavior, environmental monitoring basics, and contamination control principles.Working knowledge of cGMPs, GLPs, FDA requirements, and EU Annex 1 expectations.Ability to support risk assessments, deviation documentation, and contamination‑related investigations.Proficiency with MS Office tools and quality systems (e.g., TrackWise or similar).Ability to assist in personnel training related to aseptic and contamination control practices.Education & ExperienceBachelor’s Degree preferred in Microbiology, Biology, or a related life science.7+ years of pharmaceutical sterile manufacturing, microbiology, EM, or QA experience, including some exposure to aseptic operations or sterility assurance activities.