Sterility Assurance Lead Job Description
We are seeking a highly experienced Sterility Assurance Lead to join our client's team in Galway, Ireland.
The Role:
* Develop and implement comprehensive sterility assurance frameworks aligned with Annex I and global GMP guidelines.
* Conduct risk assessments for aseptic processes, environmental monitoring, and container closure systems to mitigate contamination risks.
* Lead initiatives to continuously improve aseptic techniques, gowning practices, and operational controls in sterile manufacturing environments.
Oversight of Environmental Monitoring and Contamination Control:
* Manage and optimize the environmental monitoring program, ensuring it effectively supports aseptic manufacturing and mitigates contamination risks.
* Investigate out-of-specification results in environmental monitoring, identify root causes, and implement corrective actions to prevent recurrence.
* Oversee the implementation and effectiveness of contamination control measures, including cleaning and disinfection practices.
Support for Sterility-Related Validations and Audits:
* Lead the scheduling and oversight of aseptic process simulations (media fills) and provide guidance during report reviews and approvals.
* Validate and revalidate sterility-related test methods and aseptic processes to ensure compliance and robustness.
* Represent the sterility assurance function in internal and external audits, addressing observations related to sterility, and driving responses and actions.
Leadership and Collaboration:
* Lead a multidisciplinary team to achieve sterility assurance objectives, providing training on aseptic and contamination control principles.
* Work cross-functionally with Quality, Manufacturing, and Engineering teams to ensure alignment on sterility assurance requirements.
* Act as a key advisor to manufacturing teams, supporting investigations and CAPAs for sterility-related deviations.
Documentation and Reporting:
* Approve and maintain documentation, including SOPs, validation protocols, contamination control plans, and trend reports.
* Organize a site-wise sterility assurance program and meetings with site SLT to showcase current trends and proposed actions.
* Track and report sterility assurance performance metrics to identify areas for improvement and enhance contamination control strategies.
Requirements:
* Bachelor's degree in Microbiology, Biotechnology, or a related discipline.
* 24 years of sterility assurance or aseptic manufacturing experience.
* Strong understanding of Annex I, US, and EMA GMP regulations.
* Proven experience in contamination control strategies, including cleaning and disinfection validation.
* Hands-on experience with isolator technology, environmental monitoring, and aseptic processing validations.
* Strong ability to mentor and develop teams, lead investigations, and drive sterility assurance initiatives.
* Experience in sterility-related risk assessments, deviation investigations, and implementing corrective/preventive actions.
* Proficient in the use of contamination control tools and monitoring systems, including MODA, Excel, and project management software.
* Excellent ability to articulate sterility assurance concepts and collaborate cross-functionally to drive compliance and process improvements.