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OBJECTIVES/
PURPOSE OF JOB
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The Microbiologist, Quality Assurance will provide technical expertise and practical execution of all activities associated with Microbiology and Sterilization to support manufacture of terminally sterilized medical devices. Position will serve as microbiology and sterilization subject matter expert for Quality Assurance activities, manufacturing operations and projects. Position will engage collaboratively and cross-functionally with other departments to provide microbiological support for activities associated with quality assurance, production, sterilization, facilities maintenance and engineering, method and process validation, product and process development. The incumbent shall contribute strategically, tactically and practically to ensure cGMP compliance of products and processes.
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KEY ACTIVITIES/
RESPONSIBILITIES
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- Provide microbiological and sterilization expertise to establish, maintain and continually improve quality control and assurance programs for manufacture of terminally sterilized medical devices. Relevant programs and activities may include, but are not limited to:
- Environmental monitoring
- Sterility assurance, including sterilizer cycle development and validation (ETO sterilization), load monitoring, product testing and load release.
- Bioburden monitoring
- Cleaning and disinfection, including validation of cleaning and disinfection processes.
- Development and validation of microbiological analytical methods.
- Stability
- Container-closure / packaging integrity
- Quality investigations
- Author and review procedures, protocols, reports, investigations and relevant sources of information to ensure that microbiology sampling, test methods and quality assurance programs are consistent with current industry practices and regulatory requirements.
- Coordinate and perform method development, validation and testing with support from internal and external microbiology laboratories for process quality, product release and project testing.
- Author and review test protocols/data/reports for validating new products and processes to ensure conformance with established specifications and related standard operating procedures.
- Anticipate /evaluate technical problems and provide recommendations for corrective actions.
- Write, collect, organize and compile data and reports for use by upper management and to comply with regulatory requirements.
- Interface with pertinent disciplines to establish, maintain and continually improve test methods and quality assurance programs.
- Review and/or develop specifications for raw materials, components and finished products.
- Evaluate, specify and justify Microbiology and Sterilization requirements for process improvement, major capital and other projects.
- Represent company on microbiology and sterilization topics during interactions with regulatory agencies, including interface with FDA inspectors.
- Participate on cross-functional teams to resolve issues.
- Coordinate microbiology and sterilization validation programs for new products (including changes to containers, closures or solutions).
- Expertise: Knowledge & Skills
- A strong scientific knowledge in areas pertaining sterilization approaches and processes (moist heat, sterility assurance, bioburden control, load monitoring).
- Knowledge of environmental, utility and facility monitoring programs, including area classifications. Familiarity with equipment installation and qualification and electronic data systems. Awareness of general cost structure pertinent to microbiological testing and validation.
- Strong problem solving and troubleshooting capabilities. Good written and verbal business communication skills. Must be able to work productively and cooperatively in a cross-disciplinary environment.
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SUPERVISE DIRECT REPORTS
(yes or no)
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No
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SCOPE OF POSITION
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See Key Activities/Responsibilities
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KEY RELATIONSHIPS
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Works with other departments such as Operations, Design Engineering, and Process Engineering as part of cross0functional team. Works with internal and external customers as needed. Works with suppliers/vendors as it relates to environmental and/or product testing.
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QUALIFICATIONS/
TRAINING
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Required Education:
- Bachelor’s degree in relevant field
- Degree in Microbiology, Molecular Biology, Biochemistry or a related science with significant microbiology coursework.
Preferred Education:
Required Skills/Qualifications:
- A strong scientific knowledge in areas pertaining sterilization approaches and processes (moist heat, sterility assurance, bioburden control, load monitoring).
- Knowledge of environmental, utility and facility monitoring programs, including area classifications. Familiarity with equipment installation and qualification and electronic data systems. Awareness of general cost structure pertinent to microbiological testing and validation.
- Strong problem solving and troubleshooting capabilities. Good written and verbal business communication skills. Must be able to work productively and cooperatively in a cross-disciplinary environment.
- Hands-on experience in addressing microbiology and sterilization related topics in regulatory submissions. Experience interacting with regulatory agencies.
- While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.
Preferred Skills/Qualifications:
- Experience with manufacturing and quality assurance of ethylene oxide terminally sterilized medical devices.
- Strong technical expertise in areas related to: sterility testing, bioburden, endotoxin, cleaning & disinfection, method validation, particulate matter, and biological indicators (manufacturing, testing & use).
- Demonstrated industry experience in several of the following areas: microbiological method development and validation, D&z value determination, cycle time reduction (CTR) studies, container-closure / packaging integrity testing (including microbial ingress, dye penetration or other methods).
- Experience in qualification of raw materials and components used in GMP manufacturing. Generation of microbiological specifications and programs in alignment with requirements and current standard practices.
Required Experience:
- Pharmaceutical / medical device industry experience, 2 years in a cGMP environment.
Preferred Experience:
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