Microbiologist II

Responsibility:

•    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.
•    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 for management review.
•    Intrepretation 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.
•    Coduct 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.
•    Coordination of sample testing via external/third-party vendor(s).
•    Communication and information exchange with affiliated Greiner facilities.
•    Other duties as assigned.

Job 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 regualtion,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.