Sterility Assurance Lead

Key Responsibilities

• Develop, implement, and maintain sterility assurance and contamination control programs for sterile manufacturing operations
• Lead the site Contamination Control Strategy (CCS) and ensure alignment with regulatory expectations and industry best practices
• Serve as SME for sterility assurance, microbiological oversight, and contamination control activities
• Define and monitor microbiological and particulate alert/action limits
• Ensure environmental monitoring programs are effectively designed, executed, evaluated, and maintained throughout the product lifecycle
• Support inspection readiness and participate in regulatory inspections and audits as the sterility assurance SME
• Prepare and support responses to regulatory observations related to sterility assurance and contamination control
• Provide oversight for terminal sterilization and aseptic manufacturing processes across development, validation, and commercial operations
• Review and approve critical manufacturing and sterilization activities including washing, filling, sterilization cycles, and environmental controls
• Review and approve validation strategies, protocols, and reports including IQ/OQ/PQ activities
• Ensure appropriate microbiological and particulate control strategies are established and maintained
• Support ongoing process verification and continued process monitoring activities
• Lead or support investigations involving microbiological deviations, contamination events, and sterility-related nonconformances
• Conduct and review risk assessments related to sterility assurance and contamination control
• Drive development and implementation of CAPAs to mitigate contamination and sterility risks
• Monitor trends and recurring issues to identify and address systemic risks

Process Oversight, Validation & Qualification

• Support technology transfers, new product introductions, and cross-functional projects
• Afford support for internal audits, gap assessments, and periodic reviews of sterility assurance systems

Cross-Functional Collaboration & Training

• Partner with Manufacturing, Engineering, Validation, Quality Control Microbiology, and Quality Assurance teams to ensure effective sterility assurance integration
• Provide coaching, training, and guidance on contamination control principles, aseptic behaviors, and sterility assurance best practices
• Support development and revision of SOPs, work instructions, and training materials
• Promote a strong quality culture focused on compliance, contamination control, and operational excellence

Continuous Improvement & Operational Support

• Participate in operational excellence and continuous improvement initiatives
• Afford support for internal audits, gap assessments, and periodic reviews of sterility assurance systems
• Support departmental and site objectives as assigned

Qualifications

• Education: Bachelor’s or Master’s degree in Microbiology, Pharmaceutical Sciences, Biotechnology, Engineering, or related scientific discipline
• Experience: Minimum 5 years of experience in sterile pharmaceutical manufacturing, injectable products, or terminal sterilization environments
• Experience: Supporting aseptic processing and/or terminal sterilization operations
• Knowledge: Strong knowledge of microbiology principles, contamination control, and cleanroom manufacturing
• Experience: Supporting validation, qualification, and regulatory compliance activities