Summary
The Microbiologist II serves as the technical subject matter expert with regards to environmental monitoring in an aseptic processing operation, and all other microbiology testing related to customer products and operations. The responsibilities of this position require effective cross-functional interaction at all levels, working within other groups to ensure compliance and drive continuous improvement of environmental control and microbiology testing. The Microbiologist II is responsible for leading and participating in technical projects related to microbiology testing processes.
Responsibilities
- Extensive experience in Microbiology and EM groups and can lead actively and/or participate in technical projects pertaining to microbiology related testing processes, including but not limited to method development, transfer and validation activities, sanitization studies, media fill qualification activities, etc
- Performs method validation/suitability for microbiological tests, specifically bioburden and sterility testing
- Performs trending analyses of data collected via environmental, personnel and utility monitoring in support of investigations, Quality Management Review, Annual Product Review, etc.; publish conclusions and make recommendations for process changes as applicable
- Investigates and documents any identified excursions or trends, including root cause analysis, impact assessment, and identification of corrective/preventative actions
- Plans and implements corrective and preventative actions (including procedure and test method revisions), and assists/measures the effectiveness of such changes
- Assesses processes and procedure changes proposed by others for potential impact on environmental monitoring/microbiology testing processes
- Participates in cross-functional meetings when needed and training sessions with manufacturing operations
- Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers
- Authors technical protocols and reports for QC microbiology
- Assists management in establishing operational objectives, goals, and project assigments
- Works through and solves complex projects/problems, where data and situation analysis are required
- Works on special projects and studies
- Writes protocols, reviews data, and writes final reports
- Prepares reports for other Microbiological tests
- Develops and prepares Environmental Monitoring Trend reports specifically for an aseptic manufacturing facility
Laboratory Support Activities
- Maintains qualification for all microbiology sampling procedures and test methods; performs testing as needed to support business needs
- Coordinates and/or conducts training for new laboratory personnel; provides technical assistance to laboratory personnel as needed
- Coordinates with contracts testing laboratories and experts as needed
- Reviews process and testing documentation as needed to ensure complete and accurate records are maintained
- Assists in the conduct of vendor audits as a microbiology subject matter expert, as needed
- Supports Agency, customer and vendor audits as needed
- Performs other tasks, projects and duties as assigned
Qualifications
- 4 year degree in biology related fields (i.e., biology, biochemistry, microbiology, etc)
- 3+ years of experience in commercial biotechnology or pharmaceutical product environment preferred
- Technical expertise in microbiology required
- Experience with environmental monitoring and microbiology testing processes required
- Experience in method development and validation preferred
- Strong analytical and problem solving skills
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