Principal Contamination Control & Sterility Assurance Specialist

Key Duties and Responsibilities

• Driving Sterility Assurance
• Maintain and support the site Contamination Control Strategy (CCS), managing gap assessments and risk assessments related to Annex 1 and Global GMP guidelines.
• Conducting risk assessments for aseptic processes, environmental monitoring, facilities and other interrelated systems to mitigate contamination risks.
• Leading initiatives to continuously improve aseptic techniques, gowning practices, and operational controls in sterile manufacturing environments.
• Establish and maintain analytics and KPI reporting methods for site Contamination Control performance.
• Support review and approval of APS Process-Specific Master Batch Records (MBRs).
• Consult as SME for Deviations during APS execution.
• 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 (deviations) in environmental monitoring, manufacturing, identifying root causes, and implementing corrective actions to prevent recurrence.
• Overseeing the implementation and effectiveness of contamination control measures, including cleaning and disinfection practices.
• Perform regular GEMBA-style assessments of manufacturing operations, including identification of deficiencies and opportunities for improvement.
• Sterility Related Validation:
• Leading the scheduling and oversight of aseptic process simulations (media fills) and providing guidance during execution, 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

• Support a multidisciplinary team to achieve sterility assurance objectives, providing training on aseptic and contamination control principles.
• Support/lead monthly contamination control committee providing technical analysis regarding EM performance and system health.
• Working cross-functionally with Quality, Quality Control, Manufacturing, Validation 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 or support quality investigations, risk assessments, and CAPA development.
• Ensure all quality records are scientifically sound, closed on time, and aligned with regulatory expectations and internal policies.

Documentation and Reporting

• Approving and maintaining documentation, including SOPs, validation protocols, contamination control plans, and trend reports.
• Tracking and reporting contamination control performance metrics to identify areas for improvement and enhance contamination control strategies.
• Write and revise relevant Standard Operating Procedures to support continuous improvement projects, CAPAs, and periodic reviews.
• Support inspection readiness plans and interact with regulatory agencies during inspections on contamination control-related subject matter.
• Affirming the impact to CCS as the functional area owner per Change Management.

Required Education and Experience

• Minimum of a Bachelor’s degree is preferred in Microbiology, Biotechnology, or a related discipline.
• Work experience: 6-10 years of sterility assurance/contamination control or GMP experience (Commercial preferred).
• 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, proven experience with clean air equipment, environmental monitoring, and aseptic processing simulations.
• 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 LIMS, Excel, and project management software.