About Your New Employer
* Global Impact: Join a company dedicated to making a difference in the lives of patients worldwide.
* Innovative Environment: Work in a cutting-edge facility with state-of-the-art technology and processes.
* Career Growth: Benefit from excellent career progression opportunities and professional development.
About Your New Job
* Driving Sterility Assurance Strategy: Develop and implement comprehensive sterility assurance frameworks, including contamination control strategies 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. Lead investigations at microbiology to ensure that appropriate root cause is identified and appropriate corrective actions are implemented.
* Documentation and Reporting: Approve and maintain documentation, including SOPs, validation protocols, contamination control plans, and trend reports. Organize a site-wide 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.
* Instrument and System Management: Support the qualification of isolators and other equipment within the laboratory.
What Skills You Need
* 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 actions.
* 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.
What’s on Offer:
* Competitive Salary: Attractive compensation package.
* Career Progression: Excellent career progression opportunities.
* Work-Life Balance: Initiatives to support a healthy work-life balance.
* Bonus Scheme: Performance-based bonus scheme.
* Health Insurance: Comprehensive health insurance coverage.
* Pension: Competitive pension plan.
What’s Next
Apply now by clicking the “Apply Now" button.
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