Zimmer Biomet is a world leader in musculoskeletal health solutions. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.
The Principal Microbiologist is responsible for leading the site microbiology activities, including but not limited to: cleanroom validation and monitoring, water system validation and monitoring, air system validation and monitoring, sterilization validation and monitoring, cleaning validation and monitoring, microbiology lab testing, and assessment of medical device biocompatibility. Additional responsibilities include documenting out of specification investigations, corrective and preventive actions, and leading cost savings and/or process improvement projects relating to microbiological control and sterilization.
- Develop validation protocols to fulfill international standards, industry, and corporate requirements.
- Collaborate with manufacturing engineering and facilities to ensure the installation, operation, and maintenance of controlled environmental systems.
- Develop and perform validations of cleanroom and controlled areas, including performing testing for validation and ongoing monitoring, and reviewing the data monthly to identify trends.
- Develop and perform validations of the water purification system and the compressed air system, including performing testing for validation and ongoing monitoring, and reviewing the data monthly to identify trends.
- Develop and perform validations of gamma sterilization, including performing quarterly dose audits, bioburden monitoring, and annually reviewing the sterilization families for changes.
- Develop and perform validations of post-manufacturing cleaning, including performing testing for validation and ongoing monitoring, and reviewing the data monthly to identify trends.
- Assess the performance of validations against international standards and internal procedures for end user sterilization, end user cleaning, biocompatibility, and manufacturing part detergent cleaning.
- Coordinate and execute accelerated and real time aging studies.
- Coordinate and execute biocompatibility studies in the support of new products.
- Investigate and document laboratory out of specification non-conformances and CAPA.
- Coordinate microbiology testing and analysis of particle size, HEPA airflow, endotoxins, and microbial growth, biocompatibility endpoints, etc.
- Prepare and conduct training sessions for the quality, R&D, and manufacturing personnel to ensure conformance to international and internal standards, aseptic cleanroom standards, sterilization standards, cleaning standards, etc.