Sterility Assurance Specialist

Agno Pharma is and end-to-end CDMO.

Position Summary

The Sterility Assurance Lead serves as the site Subject Matter Expert (SME) for sterility assurance, providing technical leadership for contamination control, aseptic processing, and microbiological quality systems. This position is responsible for ensuring compliance with cGMP requirements and supporting the continuous improvement of sterility assurance programs across sterile manufacturing operations.

Essential Responsibilities

• Serve as the site Subject Matter Expert (SME) for sterility assurance, contamination control, and aseptic processing.
• Develop, implement, maintain, and continuously improve the site's Sterility Assurance Program and Contamination Control Strategy (CCS).
• Provide technical guidance and microbiological oversight for aseptic manufacturing operations, including review of procedures, protocols, investigations, and process improvements.
• Perform microbiological risk assessments and evaluate process, equipment, facility, and procedural changes for potential contamination risks.
• Develop, maintain, and support the site's media fill (aseptic process simulation) program, including procedures, execution, trending, and investigations.
• Develop and maintain aseptic technique training, aseptic behavior training, and personnel gowning qualification programs.
• Provide technical oversight of the Environmental Monitoring Program, including trending, investigations, alert/action level assessments, and continuous improvement.
• Lead or support microbiological investigations involving environmental monitoring excursions, utility systems, contamination events, media fill failures, sterility assurance deviations, and product bioburden excursions.
• Provide technical support for microbiological testing programs, including environmental monitoring, sterility, bioburden, endotoxin, growth promotion, utility monitoring, and microbial identification.
• Support implementation of new microbiological testing capabilities, methods, laboratory investigations, and troubleshooting activities.
• Provide microbiological expertise during facility, utility, equipment, and process qualification and validation activities related to sterile manufacturing.
• Participate in change controls, deviations, CAPAs, quality risk assessments, and continuous improvement initiatives.
• Support regulatory inspections and client audits related to sterility assurance.
• Collaborate with cross-functional departments to promote contamination control, regulatory compliance, and continuous improvement throughout sterile manufacturing operations.

Qualifications

• Bachelor's degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, Biomedical Sciences, Biotechnology, or another related scientific discipline.
• Minimum of five (5) years of experience in sterility assurance, microbiology, aseptic processing, or sterile pharmaceutical manufacturing within a GMP-regulated environment (seven (7) or more years preferred).
• Experience supporting sterile pharmaceutical manufacturing operations, preferably within a sterile injectable pharmaceutical manufacturer or CDMO.
• Working knowledge of contamination control strategies, environmental monitoring, media fill programs, aseptic processing, microbiological investigations, and Quality Risk Management (QRM).
• Working knowledge of applicable cGMP regulations, GxP principles, and industry standards, including FDA, EU GMP (Annex 1), ICH, USP, ISO, PDA, and WHO guidance applicable to sterile pharmaceutical manufacturing.
• Experience supporting microbiology laboratory development or implementation of microbiological testing programs is preferred.
• Experience supporting FDA, international regulatory authority, and client inspections is preferred.
• Strong technical writing, communication, analytical, and problem-solving skills.
• Professional certifications related to microbiology, quality, or sterile manufacturing are desirable

Agno Pharma is an Equal Opportunity Employer

Benefits:

• 401(k) matching
• Health insurance
• Life insurance
• Paid time off

Work Location: In person