Senior Microbiologist

Environmental and Microbiology

• Handle microbiology tests requirements and related activities (i.e, objectionable microorganism assessments, bio burden, setting alert/action levels).
• Performs analysis to identify microorganisms to ensure that the finished product is free of microorganisms.
• Isolate and maintain cultures of bacteria or other micro-organisms In developed media, controlling moisture, aeration, temperature and nutrition.
• Study growth development and general characteristics of bacteria and other microorganisms
• Inspect condition of production environment
• Monitor environmental impacts of production activities.
• Maintains safe and healthy work environment by following standards and procedures; complying with legal regulations.
• Ensures the work areas remain clean and controlled “within the accepted limits “to comply with the international standard and internal SOP
• Assure the laboratory equipment is qualified, calibrated and within Calibration and Preventive Maintenance program.
• Operate laboratory or field equipment.
• Assists in training new personnel for the environmental, cleaning and Gowning.
• Initiate and review certificate of analysis and certificate of conformance forms
• Documenting/ recording Information
• Entering, recording, maintaining lab records and reports information in written /electronic form.
• Prepares reports related to microbiological analysis, exceeded limit results and monthly metrics. Meets the goals established for the department and promotes teamwork to achieve such.
• Record in the logbook.

Non Conformity

• Raise non conformity report in case of presence of non-conform issue.
• Updating and Using Relevant Knowledge
• Keeping up-to-date with the international standards and applying new knowledge to the job
• Efficiently Follow the standard operating procedure (SOP).
• Update microbiology /environmental processes and work instruction to comply with the standards

Analyzing Data or Information

• Identifying, Analyze and solve problems related to environmental, microbiology and sterilization issues by breaking down information.
• Analyzing information and evaluating results to choose the best solution and solve problems.
• Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes problems
• Internal Audit
• Coordinates and actively participates in the internal Audit Activities.
• Observing, receiving, and otherwise obtaining information from all relevant sources.
• Propose corrective and preventive actions if applicable
• Performs safety/environmental audits in the Microbiology Laboratory and submits documentation for the quality manager approval.

Sterilization

• Coordinates and actively participates in validations and revalidation.
• Assure the Parameters of the sterilization cycle.
• Review the sterilizer test and charts.
• Using relevant information and individual judgment to determine whether ETO processes comply with laws, regulations, or standards.
• Ensure that the sterilization cycle is accurate and as per the protocol
• Validation and revalidation
• Coordinates and actively participates in validations/Revalidation and qualifications of the laboratory, sterilization process, cleanrooms and any other validation when needed.
• Create the validation protocols for micro lab equipment lean room, sterilization validation.

Supplier Approval

• Review the supplier documents and certificates to ensure that the supplier is comply with the internal and external standards.

Health and Safety

• Comply with Health and Occupational Safety politics (HES)