Microbiologist
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Job summary
We are seeking a detail-oriented and highly skilled Microbiologist to join our Quality Control (QC) team The successful candidate will be responsible for conducting microbiological testing, ensuring compliance with GMP, USP/EP, and WHO guidelines, and supporting the integrity and sterility of ourl products.
Min Qualification:
Bachelors
Experience Level:
Mid level
Experience Length:
2 years
Job descriptions & requirements
Location: RUIRU-NAIROBI
2.0 Key Responsibilities
I. Perform routine and non-routine microbiological analysis, including:
o Sterility testing (USP <71> / Ph. Eur. 2.6.1)
o Microbial enumeration (TAMC/TYMC per USP <61>/Ph. Eur. 2.6.12)
o Environmental monitoring (viable/non-viable particles, water system testing)
II. Prepare and sterilize media, reagents, and samples.
III. Maintain laboratory equipment (autoclaves, incubators, laminar airflow hoods) and ensure calibration/qualification status.
IV. Document all activities in compliance with ALCOA+ data integrity principles.
V. Investigate Out-of-Specification (OOS) results and support deviation/CAPA processes.
VI. Validate/qualify microbiological methods and equipment as needed.
VII. Ensure adherence to safety protocols and GMP standards at all times.
3.0 Qualifications & Experience
Essential:
- Bachelor’s degree in Microbiology.
- Minimum 2–3 years of hands-on experience in a GMP pharmaceutical QC microbiology laboratory.
- Strong theoretical and practical knowledge of:
o Aseptic techniques
o Microbial identification and staining methods
o Environmental monitoring and cleanroom behavior
- Proficiency in WHO/ICH/USP/EP guidelines for microbiological testing.
- Experience with laboratory instruments (autoclaves, incubators, colony counters, LAL readers, PCR, etc.).
- Familiarity with documentation practices, including SOPs, protocols, and reports. Preferred:
- Experience in sterile product manufacturing (injectables, ophthalmics).
- Knowledge of Quality Risk Management (ICH Q9).
- Experience with method validation and laboratory investigation (OOS/OOT).
- Certification in Microbiology or Quality Assurance is a plus.
4.0 Key Competencies
- Attention to detail – ability to detect subtle deviations and ensure accuracy.
- Analytical thinking – capable of troubleshooting and investigating discrepancies.
- Communication skills – clear documentation and reporting abilities.
- Team player – able to collaborate effectively with QC, QA, and production teams.
- Adaptability – able to work in a fast-paced, regulated environment.
5.0 Compliance & Regulatory Knowledge
- GMP (WHO, EU, FDA)
- USP/EP/BP monographs
- Data Integrity (ALCOA+)
- Laboratory safety and biohazard handling
6.0 Application Process
Qualified candidates should submit:
1. Updated CV highlighting relevant experience.
2. Cover letter explaining suitability for the role.
3. Copies of academic and professional certificates.
Send applications to: kamlesh@nelent.com
Cc reception@nelent.com.
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