About the Role
Our client, a leading biopharmaceutical manufacturer, is seeking a Senior Microbiologist with expertise in Environmental Monitoring to join their quality assurance team in Queenstown, Eastern Cape. This role is vital for ensuring the microbial control and sterility of manufacturing environments and products. You will be responsible for designing and implementing comprehensive environmental monitoring programs, performing complex microbiological tests, interpreting data, and ensuring compliance with regulatory standards (cGMP, ISO). The ideal candidate will have a strong understanding of microbial physiology, aseptic techniques, and relevant analytical methodologies. We are looking for a meticulous individual with excellent problem-solving skills and a commitment to maintaining the highest quality standards. This hands‑on role offers a significant opportunity to contribute to public health and patient safety from our facility in Queenstown, Eastern Cape. Our client is dedicated to fostering a culture of continuous improvement and scientific excellence.
Key Responsibilities
- Design, implement, and manage comprehensive environmental monitoring programs for manufacturing facilities.
- Perform routine and specialized microbiological testing, including air, surface, and water sampling.
- Identify, isolate, and characterize microorganisms found in manufacturing environments.
- Conduct microbial enumeration and sterility testing on raw materials and finished products.
- Investigate environmental excursions and out-of-specification (OOS) results, determining root causes and implementing corrective actions.
- Develop and validate microbiological methods and sampling plans.
- Maintain detailed and accurate laboratory records and prepare reports for regulatory compliance.
- Ensure adherence to cGMP, ISO, and other relevant regulatory guidelines.
- Calibrate and maintain microbiological laboratory equipment.
- Train and mentor junior microbiology staff on best practices and procedures.
Requirements
- MSc or PhD in Microbiology, Applied Microbiology, or a related biological science field.
- Minimum of 5 years of experience in industrial microbiology, with a strong focus on environmental monitoring in the pharmaceutical, biotech, or medical device industries.
- Extensive knowledge of aseptic techniques, microbial identification, and enumeration methods.
- Hands‑on experience with common microbiological laboratory equipment (incubators, biosafety cabinets, microscopes, colony counters).
- Familiarity with regulatory guidelines such as cGMP, FDA, and EMA.
- Strong understanding of statistical analysis for environmental monitoring data.
- Excellent problem-solving, analytical, and critical thinking skills.
- Proficiency in scientific documentation and reporting.
- Good communication and interpersonal skills, with the ability to collaborate effectively.
- Detail‑oriented with a commitment to quality and accuracy.
Benefits
- Competitive salary package, reflecting experience and expertise.
- Comprehensive health, wellness, and disability insurance.
- Retirement savings plan options.
- Opportunities for professional development and continuing education.
- Work in a state‑of‑the‑art manufacturing and laboratory facility.
- Significant impact on product quality and patient safety.
- Generous paid time off and company holidays.
- Relocation assistance may be available for exceptional candidates.
- The role is located in Queenstown, Eastern Cape.
- The role is located in Queenstown, Eastern Cape.