Principal Microbiologist (720568)
Zimmer Biomet

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.

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

• Strong analytical / problem solving skills.
• Strong interpersonal, influence and communication skills (written/verbal/presentation) at multiple levels and across boundaries; appropriately shares viewpoint and encourages the free exchange of information and opinions.
• Strong working knowledge of ISO and AAMI standards, and US FDA and EU regulations pertaining to microbiological control, industrial sterilization, and biological safety.
• Demonstrated experience in the validation, operation, and monitoring of water and compressed air purification systems including the development of testing protocols, performance of testing for validation and routine monitoring, and analysis of data to identify trends.
• Demonstrated experience in the operation of microbiological laboratory equipment, including autoclaves, air samplers, particle counters, bacterial endotoxin testers, total organic carbon testers, incubators, and contact plate sampling and analysis.
• Demonstrated experience in the validation of equipment and microbiological test methods, including the development of protocols, work instructions, and reports.
• Demonstrated experience in the investigation and corrective action of microbiological out of specification reports and corrective and preventive action reports.
• Demonstrated experience in the validation of industrial sterilization methods, including gamma sterilization; including the performance of quarterly dose audits, bioburden monitoring, and analysis of changes.
• Demonstrated expertise in the use of computer software for the performance of microbiological monitoring and trending, such as Microsoft Office (Word, Excel, Access, PowerPoint, Visio).
• Knowledge of the performance of cleaning validation of medical devices.
• Knowledge of the performance of biological safety assessments for the biocompatibility of medical devices.
• Possesses the ability to train others in the performance of testing to international and internal standards, aseptic cleanroom gowning techniques, and means of reducing contamination.

• Bachelor of Science in Microbiology or Biology (Master's Degree is preferred)
• 6-8 years of work experience as an industrial biologist in medical device or biologics industry, or an equivalent combination of education and experience.
• Other degree programs with microbiology course work may be considered if candidates also possess 7-9 years of relevant industrial microbiology and/or sterility assurance work experience.

Up to 10%

At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. This is why we offer you a competitive rewards package that includes medical, dental, vision, life and disability insurance, wellness incentives, employee assistance programs as well as paid time off for vacation and holidays.

EOE/M/F/Vet/Disability