
Senior Environmental Microbiologist Specialist
2 weeks ago
Job Title: Microbiologist
Key Responsibilities:
- Perform regular monitoring of controlled areas, including air, surfaces, and personnel, to ensure aseptic conditions are maintained.
- Analyze purified water and raw water samples for microbial contaminants.
- Carry out Microbial Limit tests, BET, Sterility testing, and other related procedures on water, APIs, and KSMs.
- Support cleaning validation activities by conducting swab/rinse microbiological analysis.
- Conduct microbiological validation studies, such as filter integrity testing and media fills for aseptic processes.
- Participate in the qualification of controlled areas, equipment, and utilities, including HVAC, water systems, and compressed air.
- Develop and review Standard Operating Procedures (SOPs), protocols, and reports related to microbiological operations.
- Maintain accurate and compliant microbiological records according to GMP and data integrity requirements.
- Support regulatory inspections and customer audits by providing microbiology-related information and expertise.
- Investigate out-of-specification (OOS) or out-of-trend (OOT) results related to microbial analysis.
- Analyze root causes of microbial contamination and propose corrective actions.
- Assess microbiological risks associated with processes and systems.
- Maintain a collection of microbial cultures and reference strains.
- Evaluate and maintain the calibration and qualification of laboratory instruments, including incubators, autoclaves, laminar airflow workbenches, and microscopes.
- Ensure safe handling, disposal, and biosafety practices for microbial cultures.
- Train production and quality staff on microbiological hygiene and aseptic practices.
- Contribute to the continuous improvement of contamination control strategies.
Requirements:
- Bachelor's degree in Microbiology, Biology, or a related field.
- Proven experience in microbiological analysis and validation.
- Strong understanding of GMP and data integrity principles.
- Excellent communication and interpersonal skills.
- Ability to work in a team environment and provide training to others.
We offer:
- A competitive compensation package.
- A dynamic and supportive work environment.
- Ongoing training and development opportunities.
- The chance to contribute to the success of our organization.
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