Microbiologist

6 days ago

Singapore BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE. LTD. Full time

**Job Summary**:

- To own and support routine operations microbiology laboratory functions. This includes full range of cleanroom environmental monitoring activities, and product related testing activities.
- To assist with the reviewing of microbiological test data, laboratory investigations in the absence of the lab manager
- The Microbiologist is also to ensure adequate resouses (e.g. supplies, trained analysts, equipment) in the microbiology lab needed to support microbiological testing activities within the organisation
- To lead the microbiology lab team to continuously improve and lean the laboratory operations to achieve operational excellence.
- Ensure testing elements (e.g. methods, equipments, lab practices) are in compliance various regulatory requirements.
- Perform routine/non-routine microbiological testing on raw materials, in-process samples, finished products (pre and/or post sterilize), as well as environmental monitoring
- Perform quality checks for media used in testing
- Review product/environment microbial trends, highlight emerging trends, uncommon bacteria occurance
- Coordinate 3rd party lab microbiological testing activities (e.g. bacterial identification, endotoxins test)
- Qualify and maintain all laboratory equipment to ensure they are fit for its intended usage, with proper calibration and maintenance program established
- Ensure continuous flow of all necessary resources (e.g. supplies, trained analysts, equipment) to enable smooth activities in the laboratory
- Ensure accuracy, integrity, traceability and reliability of test report generated, as well as sample information submitted
- Maintain and prepare work instructions to ensure compliance with reference standards
- Lead laboratory equipment and test method validation / revalidation activities through establishing protocols, execution, and report documentation
- Provide support for personnel qualification and re-qualification, and cleanroom re-qualification
- Perform and/or support investigation and documentation of non-compliance or out-of-spec situations.
- Lead and/or review internal laboratory investigations
- Manage training activities for newcomers and qualify them on microbiological test methods
- Perform other duties as assigned by superiors
- Adhere to all EHS rules, regulations and risk assessments and take adequate control measures in preventing injuries to themselves and others as well as prevention of pollution to the environment

**Job Requirements**
- Bachelor in Science discipline (e.g. Pharmaceuticals Sci, Microbiology, Biological Science)
- At least 2-3 years of relevant experience in a laboratory environment
- Microsoft Office Applications
- Cleanroom/environmental control experience is essential
- Good knowledge of microbiological test methods (e.g. Bioburden, endotoxins, sterility tests)
- Knowledge of aseptic techniques, and GLP
- Excellent Interpersonal and communication skill
- High level of integrity
- Able to work under stress and deliver work schedules
- Self starter and independent
- Knowledgeable of applicable standards such as ISO 13485, preferably to have knowledge on ISO14644, ISO14698, ISO11737 and ANSI/AAMI-ST72
- Good analytical and problem solving skills

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