Perform Microbiological testing and examination according to valid procedures; such as Bioburden, Endotoxin, Sterility, Growth Promotion, and Environmental Monitoring.
Execute method validations for medical device and non-medical device for bioburden and sterilization according to ISO standards.
Assist in the development and implementation of processes and facility monitoring to ensure effective contamination control strategies are established.
Assist in the development of facility gowning program.
Act as an SME for method validation for new products.
Author SOPs, test procedures, and assist in creating validation protocols and reports for the lab.
Data entry for trends and reporting on them for management review.
Interpretation of sterilization dose audit results and elevation of the data trends as needed.
Test non-conforming product to resolve QIR issues as well as investigate returned products via complaint processing system.
Assist in investigations along with other departments to identify root cause.
Completion of assigned CAPA as needed.
Conduct aseptic technique training and Hygiene regulation training for other departments.
Review and maintain stock of consumables (supplies and equipment) for Microbiology department.
Purchase requisition and material transfer in SAP.
Coordination of sample testing via external / third-party vendor(s).
Other duties as assigned.
Requirements :
Minimum Bachelor’s or Master’s Degree in microbiology, or related field.
5 years of relevant work experience in GMP-controlled laboratory environment.
Experience in Medical Device, Pharmaceutical, and / or regulated industry is preferred.
Basic Knowledge of medical device regulation, industry, and international standards.
Basic understanding of computer systems (Word, Excel, Outlook, and instrument dedicated).
Knowledge of gamma and ebeam sterilization, and ISO 11137 requirements.