Microbiologist II

Job Summary:

The Microbiologist II works independently on Test Section projects as assigned in establishing and maintaining the microbiology programs including environmental monitoring, bioburden, bacteria endotoxin and utilities (water & compressed air) testing. Follows current ISO, QSR and government regulations for all job functions. Communicates and provides technical assistance to Quality Assurance, Engineering and Production personnel concerning microbiological issues. Represents TMC as a member of professional, industry and government organizations, such as AAMI, ASTM and ASM.

Job Details:

• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Provides technical direction for development and continuous improvement of programs for related microbiological test methodology in compliance with external standards and internal quality systems.
• Assists and interacts with internal customers related to clean room practices, auditing, and microbiological testing.
• Operate and maintain laboratory equipment, perform equipment troubleshooting and maintenance, recognize errors, identify root causes, apply process improvement; maintain excellent working knowledge of laboratory equipment.
• Provides guidance and methodologies for LAL, bioburden, environmental monitoring, and utilities (water and compressed air).
• Review and approve test results and reports. Conduct investigations regarding out of limit specifications (OOL) results and address and manage deviations related to micro procedures.
• Responsible for training technicians in aseptic technique and general microbiology.
• Trend and analyze environmental monitoring, product bioburden & bacteria endotoxin data.
• Perform clean room risk assessment for environmental monitoring.
• Write protocol and reports for new clean room start-up and modifications.
• Executes test methods and equipment validations.
• Perform routine environmental monitoring, product bioburden and bacterial endotoxin.
• Perform microbial identification program using gram staining technique.

Perform gap assessment to ensure that current plant policy align with current FDA, ISO and

• USP requirements.
• Drive continuous improvement of the microbiology programs.
• Serve as subject matter expert & participation during internal and external audits.
• Write quarterly and annual review of environmental monitoring, bioburden & bacteria endotoxin data and make recommendations based on the analysis.
• Provide assistance and knowledge during regulatory/compliance body audits (FDA, ISO, etc.).
• Apply cGLP, cGMP, AAMI, ISO, FDA USP guidelines to microbiological development validation such as bioburden, bacterial endotoxin, and environmental monitoring.
• Assist in scheduling routine validations and equipment certifications with outside contractors.
• Assist in performing daily laboratory work as required.
• Maintains laboratory inventory and orders supplies.
• Other duties/responsibilities as assigned by manager.
• Position Requirements:

• Knowledge, Skills and Abilities (KSAs)
• Knowledge and demonstrated experience in performing a variety of microbiological test methods (Bioburden, bacterial endotoxin, water testing, environmental monitoring, microbial isolation and characterization)
• Knowledge of microbial identification system, e.g., Vitek instrumentation
• Knowledge of quality standards (ISO, FDA, GMPs, GLPs) and microbiological standard related to area of expertise.
• Knowledge of requirements for controlled manufacturing areas (ISO 14644) including requirements for commissioning, risk assessment and certification of clean rooms.
• Knowledge of government regulation and industry guidelines for medical device sterilization.
• Working knowledge of Good Laboratory and Good Manufacturing practices.
• Ability to clearly communicate information via verbal presentations and in writing.
• Working knowledge of Microsoft office applications including Word, Excel, PowerPoint, Outlook and MS Project.

• Background Experiences

• 4-year degree in Microbiology, Biological Sciences or Engineering
• At least 3 years microbiological experience in the medical device/ pharmaceutical industry, including clean room and environmental monitoring testing, bacteria endotoxin/LAL and bioburden testing is preferred.
• Experience developing and implementing Validation protocol.