Sterility Assurance and Microbiology Specialist

Role Summary

Based in Swiftwater, PA, the Sterility Assurance and Microbiology Specialist serves as the Subject Matter Expert for contamination control, aseptic processes, and sterility assurance programs. You will lead risk assessments, investigations, and CAPA to ensure product quality and patient safety. You will advise teams on sterility assurance best practices, participate in global Centers of Excellence, and develop SOPs and training materials to support regulatory compliance and site-level execution.

Responsibilities

• Serve as Subject Matter Expert for contamination control, aseptic processes, and sterility assurance programs including process simulations, traffic patterns, gowning procedures, and disinfection protocols.
• Conduct comprehensive risk assessments related to contamination control and develop mitigation strategies to ensure product quality and patient safety.
• Monitor site activities and performance metrics for contamination control systems, ensuring compliance with procedures through regular shop floor presence and GEMBA walks.
• Lead investigations following contamination control failures, propose effective corrective and preventive actions (CAPA), and implement sustainable solutions.
• Advise teams on sterility assurance best practices, participate in global Centers of Excellence, and implement shared best practices at the site level. Review contamination control monitoring data to identify trends, propose process improvements, and optimize sterility assurance systems.
• Author, update, and approve departmental documents including SOPs, protocols, reports, and training materials to ensure regulatory compliance.
• Participate in regulatory inspections and audits, presenting and defending materials related to sterility assurance and microbiology with technical expertise.
• Mentor team members on aseptic manufacturing processes and facility design, contributing to the development of technical capabilities within the organization.

Qualifications

• Required: Bachelor's degree in Science or Engineering; Minimum 5 years of experience in a cGMP-controlled pharmaceutical or vaccine manufacturing environment with demonstrated knowledge of regulatory requirements and Good Manufacturing Practices; Expertise in contamination control, aseptic processes, and sterility assurance programs including process simulations, traffic patterns, gowning procedures, and/or disinfection protocols; Ability to meticulously review and analyze documentation, processes, and products to ensure compliance with regulatory standards and Sanofi Quality requirements; Strong communication skills to effectively interact across all organizational levels (shop floor to management) and present complex technical subjects to diverse audiences; Demonstrated ability to organize and lead multi-disciplinary investigations with strong problem-solving capabilities and implementation of effective CAPA.
• Preferred: Science or Engineering fields strongly preferred.

Skills

• Contamination control
• Aseptic processing
• Sterility assurance program management
• Process simulations
• GEMBA walks / shop-floor presence
• Regulatory inspections and audits
• Technical documentation (SOPs, protocols, reports, training materials)
• Cross-functional collaboration
• Data interpretation and trend analysis

Education

• Bachelor's degree in Science or Engineering (required)