Work Flexibility: Onsite

What you will do:

The Microbiology & Sterilization Staff Engineer provides technical leadership and subject-matter expertise in microbiology, sterilization processes, and contamination control. This role supports product development, manufacturing, and regulatory compliance by ensuring microbial control strategies meet applicable standards while driving continuous improvement and risk reduction across the organization.

• Serve as subject matter expert in EO sterilization and ensure compliance with ISO 11135 requirements for both existing and new products.
• Lead and support sterilization process development, validation, and requalification while maintaining sterility assurance levels (SAL).
• Evaluate product and packaging changes for sterilization impact and author protocols, reports, and change controls.
• Develop, validate, and maintain microbiological test methods, including bioburden, sterility, endotoxin, and environmental monitoring.
• Investigate microbiological deviations, nonconformances, and CAPAs to ensure timely resolution and risk mitigation.
• Collaborate with external sterilization vendors, laboratories, and cross-functional teams to achieve sterilization objectives.
• Support contamination control strategies, cleanroom monitoring programs, and ongoing compliance with regulatory and quality standards.
• Support internal, supplier, and regulatory audits, including review and approval of technical documentation, SOPs, and risk assessments.

What you need:

• Bachelor’s degree in Microbiology, Biology, Biomedical Engineering, Chemical Engineering, or related field.
• 5+ years of experience in microbiology and/or sterilization within a regulated industry.
• Strong knowledge of microbiological testing and sterility assurance.
• Experience working under FDA, ISO, or GMP environments.

Travel Percentage: 20%