Prepare culture media, reagents, and perform microbiological testing including sterility, endotoxin (LAL), and bioburden tests.
Support sterilization validation (steam, EtO, gamma, E-beam) and monitor biological indicators.
Conduct environmental monitoring of cleanrooms (air, surface, personnel) and analyze EM data against action/alert limits.
Perform microbiological analysis of water systems (Purified Water, WFI, clean steam) and support system validation.
Validate and qualify microbiological methods, including sterility and bioburden testing, as per regulatory standards.
Investigate contamination events, support CAPA implementation, and ensure compliance with cGMP, ISO 13485, and FDA/MDR requirements.
Train and monitor personnel on aseptic techniques, gowning, and contamination control in controlled environments.
Maintain accurate documentation, trend reports, and support internal/external audits.