Sterility Assurance Lead

A Sterility Assurance Lead is required by CareerWise Recruitment for our Galway based client. The Sterility Assurance Lead (Senior Microbiology Team Lead) plays a pivotal role in ensuring the Sterility of Injectable products through robust Contamination Control and Sterility Assurance strategies. This role extends beyond Microbiological Testing to encompass comprehensive oversight of Aseptic Manufacturing, Contamination Risk Management, and adherence to global Regulatory Requirements. It involves close collaboration across departments to drive Sterility Assurance initiatives while fostering a culture of quality excellence. We are open with candidates across European Union, with the correct VISA, who is willing to relocate to Galway, Ireland.

THE ROLE:

• Driving Sterility Assurance Strategy:
  • Developing and implementing comprehensive sterility assurance frameworks, including contamination control strategies aligned with Annex I and global GMP guidelines.
  • Conducting risk assessments for aseptic processes, environmental monitoring, and container closure systems to mitigate contamination risks.
  • Leading initiatives to continuously improve aseptic techniques, gowning practices, and operational controls in sterile manufacturing environments.
• Oversight of Environmental Monitoring and Contamination Control:
  • Managing and optimizing the environmental monitoring program, ensuring it effectively supports aseptic manufacturing and mitigates contamination risks.
  • Investigating out-of-specification results in environmental monitoring, identifying root causes, and implementing corrective actions to prevent recurrence.
  • Overseeing the implementation and effectiveness of contamination control measures, including cleaning and disinfection practices.
• Support for Sterility-Related Validations and Audits:
  • Leading the scheduling and oversight of aseptic process simulations (media fills) and providing guidance during report reviews and approvals.
  • Validating and revalidating sterility-related test methods and aseptic processes to ensure compliance and robustness.
  • Representing the sterility assurance function in internal and external audits, addressing observations related to sterility, and driving responses and actions.
• Leadership and Collaboration:
  • Leading a multidisciplinary team to achieve sterility assurance objectives, providing training on aseptic and contamination control principles.
  • Working cross-functionally with Quality, Manufacturing, and Engineering teams to ensure alignment on sterility assurance requirements.
  • Acting as a key advisor to manufacturing teams, supporting investigations and CAPAs for sterility-related deviations.
  • Lead investigations at microbiology to ensure that appropriate root cause is identified and appropriate corrective actions are implemented.
• Documentation and Reporting:
  • Approving and maintaining 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.
  • Tracking and reporting sterility assurance performance metrics to identify areas for improvement and enhance contamination control strategies.
• Instrument and System Management:
  • Supporting the qualification of isolators, and other equipment within the laboratory.

REQUIREMENTS:

• Educational Background: A Bachelor’s degree in Microbiology, Biotechnology, or a related discipline, with 2–4 years of sterility assurance or aseptic manufacturing experience.
• Regulatory Knowledge: Strong understanding of Annex I, US, and EMA GMP regulations, with practical experience in regulatory audits.
• Aseptic Process Expertise:
  • Proven experience in contamination control strategies, including cleaning and disinfection validation.
  • Hands-on experience with isolator technology, environmental monitoring, and aseptic processing validations.
• Leadership Skills: Strong ability to mentor and develop teams, lead investigations, and drive sterility assurance initiatives.
• Risk Assessment & Problem-Solving: Experience in sterility-related risk assessments, deviation investigations, and implementing corrective/preventive
• Technical Proficiency: Proficient in the use of contamination control tools and monitoring systems, including MODA, Excel, and project management software.
• Communication & Collaboration: Excellent ability to articulate sterility assurance concepts and collaborate cross-functionally to drive compliance and process improvements.
• This role focuses on establishing a robust sterility assurance culture, ensuring patient safety through the highest levels of contamination control, process integrity, and regulatory compliance.

Please call Tom Devaney today for further information on 091-758771 or email: tdevaney@careerwise.ie

CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. 

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

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