Microbiologist

Job Descriptions & Requirements

Location: RUIRU-NAIROBI

Key Responsibilities

Perform routine and non-routine microbiological analysis, including:

• Sterility testing (USP / Ph. Eur. 2.6.1)
• Microbial enumeration (TAMC/TYMC per USP /Ph. Eur. 2.6.12)
• Environmental monitoring (viable/non-viable particles, water system testing)

Prepare and sterilize media, reagents, and samples.

Maintain laboratory equipment (autoclaves, incubators, laminar airflow hoods) and ensure calibration/qualification status.

Document all activities in compliance with ALCOA+ data integrity principles.

Investigate Out-of-Specification (OOS) results and support deviation/CAPA processes.

Validate/qualify microbiological methods and equipment as needed.

Ensure adherence to safety protocols and GMP standards at all times.

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 
• Aseptic techniques
• Microbial identification and staining methods
• 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, ophthalmic).
• 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.

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.

Compliance & Regulatory Knowledge

• GMP (WHO, EU, FDA)
• USP/EP/BP monographs
• Data Integrity (ALCOA+)
• Laboratory safety and biohazard handling

Skills Required:

• Health / Medical
• Pharmaceutical