Principal Scientist, Microbiology
The Principal Scientist, Microbiology reports to the Director, Sterility Assurance, in the Quality Shared Services group. This individual has responsibility for supporting key strategic initiatives and providing technical expertise to the manufacturing sites in relation to the microbiological control of commodities, terminal sterilization and aseptic manufacturing processes. This individual assists in the development of strategic initiatives for continual improvement in the areas of microbiological control, sterilization, and aseptic manufacturing, The Principal Scientist, Microbiology must demonstrate a strong working knowledge of regulatory expectations for environmental monitoring, routine microbiological testing and sterilization processes. The Principal Scientist, Microbiology must also demonstrate strong leadership through the development of strategies for addressing high complexity issues and continuous improvement of the microbiological control program. This individual is responsible for supervising the development of new test methods to demonstrate Maintenance of Sterility for first-of-the kind devices for our business critical projects.Essential Duties & Responsibilities
Knowledge, Skills & Qualifications
- Provide Sterility Assurance and microbiology expertise to ICU Medical manufacturing sites by benchmarking across global requirements, developing and implementing corporate standards specific to aseptic manufacturing and microbiological control, facilitating knowledge sharing between manufacturing sites, serving as a mentor for developing talent and serving as a Subject Matter Expert for facilitating disposition/ resolution of assigned High Level Investigations related to sterility assurance and microbiology
- Maintain a complete understanding and ensure compliance with cGLP, cGMP, ANSI, AAMI, ISO, and regulatory agency (i.e. FDA, EMEA, TGA, etc.) requirements as well as industry standards regarding sterilization and microbiological quality control.
- Troubleshoot complex issues and defend environmental monitoring and microbiological testing practices and during regulatory inspections.
- Develop or revise and issue corporate policies/procedures specific to sterilization and microbiological control.
- Support and participate in audit activities of external EtO/Gamma Irradiation/E-beam sterilization sites, internal Moist Heat sterilization/Parametric Release sites, and support laboratories for compliance with internal policies and procedures and external regulatory agency requirements.
- Process related DPCRs and DCRs as change owner to support ICU Medical manufacturing sites for global processes related to Sterility Assurance as required.
- Minimum of 8-12 years of experience in the pharmaceutical, biotechnology or medical device industry.
- Prior experience in Microbiological Quality technical support for sterile products manufacturing, including Aseptic and Terminally Sterilized products.
- Knowledge of sterilization practices and theoretical concepts, including Sterile Filtration, Moist Heat, Dry Heat, Gas, and Irradiation.
- Knowledge of cGMP and Good Laboratory Practices (GLPs)
- Previous demonstrated responsibility for microbiology activities
- Complete understanding and wide application of technical principles, theories, concepts and techniques
Education and Experience
- Bachelor's degree in Microbiology, Chemistry, Food Science, related scientific discipline
- Minimum of 8 years of experience in the pharmaceutical, biotechnology or medical device industry required; 12 years of experience preferred
- Must be at least 18 years of age
- Must pass pre-employment drug screen and background check
- Typically requires travel 5-20% of the time
Physical Requirements and Work Environment
- This job operates in a professional office environment and routinely uses standard office equipment.
- Must be able to occasionally move and lift objects of up to 25 lbs. - carrying boxes of test samples for shipping to the contract labs.
We are an Equal Employment Opportunity Employer, Female/Minority/Veterans/Disabled/Sexual Orientation/Gender Identity.