Microbiologist II

Responsibilities

• Carry out Microbiological testing and examination according to valid procedures such as Biobuden, Endotoxin, Sterility, Growth Promotion, cell growth (cell culture), and Environmental Monitoring.
• Execute method validations for medical device and non-medical device for bioburden and sterilization according to ISO standards.
• Lead sterilization validation projects for new and existing products according to ISO 11137.
• Support routine dose audits, requalification, dose setting, and dose mapping studies.
• Aid in the development and implementation of processes and facility monitoring to ensure effective contamination control strategies are established.
• Aid 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 for management review.
• Interpretation of sterilization dose audit results and elevation of the data trends as needed.
• Test non-conforming product to resolve QIR/NCR issues as well as investigate returned products via complaint processing system.
• Assist in investigations along with other departments to identify root cause.
• Support CAPA investigations by identifying root causes and implementing corrective actions.
• Participate in internal audits and support external regulatory inspections.
• Conduct aspetic technique training and Hygiene regulation training for other departments.
• Review and maintain stock of consumables (supplies and equipment) for Microbiology department.
• Purchase requestion and material transfer in SAP.
• Coduct aspetic technique training and Hygiene regulation training for other departments.
• Coordination of sample testing via external/third-party vendor(s).
• Communication and information exchange with affiliated Greiner facilities.
• Other duties as assigned.

Requirements

• Minimum Bachelor’s or Master’s Degree in microbiology, or related field.
• Minimum 3 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, ISO 13485 and ISO 11137 requirements.