Microbiologist

Perform microbiological testing of raw materials, water, environment, and finished products.

Conduct environmental monitoring (air, surface, personnel) in controlled areas.

Support sterility testing, bioburden testing, and endotoxin testing as applicable.

Monitor and validate cleanroom conditions and aseptic practices.

Prepare, review, and maintain microbiology-related SOPs, protocols, and records.

Ensure compliance with ISO 13485, ISO 14644, ISO 11737, and regulatory guidelines (CDSCO/CE/FDA as applicable).

Investigate out-of-trend (OOT) or out-of-specification (OOS) results and support CAPA.

Assist in audits (internal, external, regulatory) and respond to microbiology observations.

Support validation activities (cleaning, sterilization, environmental monitoring).