About the Role
Our client, a prominent pharmaceutical manufacturing company, is seeking a highly skilled and experienced Senior Pharmaceutical Microbiologist to lead their microbiology laboratory operations in Benoni . This role is critical for ensuring the microbial quality and safety of pharmaceutical products through rigorous testing and robust environmental monitoring programs. The ideal candidate will possess a strong background in pharmaceutical microbiology, a deep understanding of aseptic techniques, and extensive experience with various microbiological testing methods. You will be responsible for overseeing laboratory activities, ensuring compliance with regulatory standards, and contributing to the overall quality assurance of the company's products manufactured in Gauteng , specifically in Benoni . We are looking for an individual with excellent analytical skills and a commitment to maintaining the highest standards of microbial control.
Key Responsibilities
- Oversee all aspects of the pharmaceutical microbiology laboratory, including sample testing, data analysis, and result reporting.
- Develop, validate, and implement microbiological test methods for raw materials, in-process samples, finished products, and environmental monitoring.
- Conduct microbial limit tests, sterility tests, bacterial endotoxin tests (BET), and antimicrobial effectiveness tests (AET).
- Design and manage environmental monitoring programs for cleanroom facilities, including air, surface, and personnel monitoring.
- Investigate out-of-specification (OOS) microbiological results and environmental excursions, identifying root causes and implementing CAPAs.
- Ensure compliance with cGMP, USP, EP, and other relevant regulatory guidelines for microbiological testing.
- Manage the qualification and calibration of microbiological laboratory equipment.
- Train and mentor junior microbiologists and laboratory technicians.
- Review and approve microbiological data, reports, and validation documentation.
- Stay current with advancements in pharmaceutical microbiology and relevant regulatory expectations.
Requirements
- Master's degree or Ph.D. in Microbiology, Pharmaceutical Sciences, or a related field.
- Minimum of 5-7 years of experience in pharmaceutical microbiology, with at least 2 years in a supervisory or senior role.
- Extensive hands‑on experience with aseptic techniques, microbial enumeration, sterility testing, and microbial identification.
- In‑depth knowledge of cGMP requirements for microbiological control, environmental monitoring, and validation.
- Proficiency in performing and interpreting bacterial endotoxin testing (e.g., LAL method).
- Experience with pharmacopoeial methods (USP, EP) and regulatory guidelines.
- Strong problem‑solving, analytical, and documentation skills.
- Excellent communication and interpersonal skills, with the ability to lead a team effectively.
- Familiarity with bioburden reduction strategies and cleanroom classification is desirable.
- Proficiency in using laboratory information management systems (LIMS) is a plus.
Benefits
- competitive salary, performance‑based bonuses, and a comprehensive benefits package, including medical, dental, and vision coverage, along with a retirement fund.
- ongoing training, workshops, and support for attending industry conferences.
- Generous annual leave, sick leave, and public holidays are provided.
- life insurance.
- disability coverage.
- potential relocation assistance for candidates moving to Benoni .
Join a leading pharmaceutical company and contribute to the safety and quality of life‑saving medicines.