Job Overview
A Contamination Control Specialist is required by our client to play a pivotal role in ensuring the Sterility of Injectable Products through robust Contamination Prevention and Assurance Strategies.
This role extends beyond Microbiological Testing to encompass comprehensive oversight of Aseptic Manufacturing Processes, Contamination Risk Management, and adherence to global Regulatory Requirements. It involves close collaboration across departments to drive Contamination Prevention Initiatives while fostering a culture of Quality Excellence.
Responsibilities
1. Developing and Implementing Contamination Prevention Frameworks: Developing and implementing comprehensive contamination prevention frameworks, including 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.
2. 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.
3. Support for Contamination-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 contamination assurance function in internal and external audits, addressing observations related to sterility, and driving responses and actions.
4. Leadership and Collaboration: Leading a multidisciplinary team to achieve contamination assurance objectives, providing training on contamination prevention and control principles. Working cross-functionally with Quality, Manufacturing, and Engineering teams to ensure alignment on contamination assurance requirements. Acting as a key advisor to manufacturing teams, supporting investigations and CAPAs for contamination-related deviations. Lead investigations at microbiology to ensure that appropriate root cause is identified and appropriate corrective actions are implemented.
5. Documentation and Reporting: Approving and maintaining documentation, including SOPs, validation protocols, contamination control plans, and trend reports. Organizing site-wide contamination assurance programs and meetings with site SLT to showcase current trends and proposed actions. Tracking and reporting contamination assurance performance metrics to identify areas for improvement and enhance contamination control strategies.
6. Instrument and System Management: Supporting the qualification of isolators, and other equipment within the laboratory.
Requirements
* Education Background: A Bachelor's degree in Microbiology, Biotechnology, or a related discipline, with 2–4 years of contamination assurance or aseptic manufacturing experience.
* Regulatory Knowledge: Strong understanding of Annex I, US, and EMA GMP regulations, with practical experience in regulatory audits.
* Contamination 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 contamination prevention initiatives.
* Risk Assessment & Problem-Solving: Experience in contamination-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 contamination prevention concepts and collaborate cross-functionally to drive compliance and process improvements.
* This role focuses on establishing a robust contamination assurance culture, ensuring patient safety through the highest levels of contamination prevention, process integrity, and regulatory compliance.