Role Overview
The Senior Sterilization Microbiologist provides advanced technical leadership for sterility assurance activities supporting medical device manufacturing across multiple sites. Acting as a senior microbiology subject matter expert, this role ensures compliance with global regulatory expectations and international sterility standards while providing oversight and direction for critical microbiological and sterilization activities.
The position plays a key role in maintaining robust sterility assurance systems, supporting regulatory interactions, driving continuous improvement, and mentoring microbiology teams within a complex, multi-site environment.
Key Responsibilities
- Provide technical leadership and accountability for sterility assurance programs across multiple manufacturing locations, including environmental monitoring, utility monitoring, bioburden, and endotoxin testing
- Review, approve, and provide oversight of gamma and ethylene oxide sterilization validations and periodic requalifications in accordance with international standards
- Evaluate and approve sterilization supplier validation activities and technical documentation
- Perform statistical analysis, trending, and interpretation of microbiological data to ensure process control and prompt corrective actions
- Serve as technical lead for microbiology-related non-conformances and CAPA, including root cause analysis, action approval, and effectiveness verification
- Act as the microbiology technical representative in cross-functional forums addressing product, process, and quality-related challenges
- Provide subject matter expertise during supplier quality audits and support oversight of critical vendors
- Identify opportunities for process improvement to enhance data robustness, stability, and statistical control
- Contribute to the development, harmonization, and maintenance of global microbiology and sterility assurance procedures
- Support new product introductions by ensuring alignment with established and validated sterilization processes
- Review and approve biocompatibility assessments for materials, components, and consumables
- Provide technical input to sterility-related risk assessments and support resolution of complex quality issues
- Mentor and coach microbiology professionals and cross-functional stakeholders
- Lead microbiology-focused projects from initiation through completion
- Travel may be required to support site activities and audits
Qualifications & Experience
- Degree in Microbiology or a related scientific discipline
- Extensive industry experience in microbiology, including significant experience within the medical device sector
- Strong working knowledge of international standards and regulatory requirements related to medical device microbiology and sterility assurance
- Proven experience with sterilization processes and validation activities (e.g., gamma, ethylene oxide)
- Experience supporting or interacting with regulatory authorities and notified bodies
- Advanced capability in statistical analysis and interpretation of microbiological data
- Demonstrated ability to provide senior technical leadership in a multi-site or global operating environment
