Key Responsibilities:
Conduct routine microbiological testing (water, environment, raw materials, in-process & finished products).
Perform environmental monitoring of cleanrooms, utilities, and aseptic areas.
Support media fill, sterility testing, endotoxin testing, and microbial limits testing.
Ensure compliance with cGMP, SOPs, and regulatory guidelines (USFDA, EU, WHO, etc.).
Review and document microbiological data, deviations, and OOS/OOT investigations.
Participate in validation activities (cleanroom, equipment, sterilization, and disinfectant efficacy).
Coordinate with production and QA for contamination control and continuous improvement.
Qualifications & Skills:
M.Sc./B.Sc. in Microbiology or related discipline.
2–5 years of experience in microbiology within sterile/SVP manufacturing.
Knowledge of aseptic techniques, cleanroom classifications, and regulatory guidelines.
Strong documentation, analytical, and problem-solving skills.