Microbiologist - #1127550

Summary

• To carry out routine microbiology laboratory operations, this includes full range of cleanroom environmental monitoring activities, and product related testing activities;

• Expected to be competent in own area of scope (i.e. Environmental Monitoring or Product Testing), include rendering support and guidance to other team members in the organisation on non-routine microbiological testing for validation and engineering studies, and resolution of causes to operational issues;

• To assist with reviewing of microbiological test data, laboratory investigations in the absence of the lab manager or person in charge;

• Ensure testing elements (e.g. methods, equipment, and lab practices) are in compliance with various regulatory requirements;

Responsibility

• Perform routine/non-routine microbiological testing on raw materials, in-process samples, finished products (pre and/or post sterilize), as well as environmental monitoring according to established procedures.

• Perform quality checks for media used in testing and maintain masters / cultures used for testing.

• Implementing and maintaining the lab environmental conditions.

• Review product/environment microbial trends, highlight emerging trends, uncommon bacteria occurrence.

• Coordinate 3rd party lab microbiological testing activities (e.g. bacterial identification, endotoxins test).

• Qualify and maintain respective 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.

• Ensure proper filling and retention of test reports.

• 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.

• Responsible for respective training activities for newcomers and qualify them on microbiological test methods.

• 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.

• Monitor documentation and implementation of ISO/IEC 17025.

Requirement

• Bachelor/Diploma in Science discipline (e.g. Pharmaceuticals Science, Microbiology, Biological Science)

• At least 2-3 years of relevant experience in a laboratory environment

• 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, a self-starter and ability to work independently

• Able to work under stress and deliver work schedules

• Knowledgeable of applicable standards such as ISO 13485, ISO/IEC 17025, preferably to have knowledge on ISO14644, ISO17141, ISO11737 and ANSI/AAMI-ST72

• Experience in Quality Assurance or medical device/manufacturing environment would be an advantage

• Relevant Microsoft Office Applications

• Preferable to have experience in QMS audit/internal audit/supplier audit in the context of ISO13485/9001 or the equivalence

• Good analytical and problem solving skills (FMEAs, 5-whys, 8D etc…)