Microbiologist

Summary

• To carry out routine microbiology laboratory operations, including a 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), including rendering support and guidance to other team members in the organization on non-routine microbiological testing for validation and engineering studies, and resolution of operational issues.
• To assist with reviewing microbiological test data and 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.

Roles & Responsibilities

• Perform routine/non-routine microbiological testing on raw materials, in-process samples, finished products (pre and/or post sterilization), as well as environmental monitoring according to WI.
• Perform quality checks for media used in testing.
• Review product/environment microbial trends and highlight emerging trends and uncommon bacteria occurrences.
• 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 intended usage, with a 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 reports 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.
• Responsible for respective training activities for newcomers and qualify them on microbiological test methods.
• Adhere to all EHS rules, regulations, and risk assessments, taking adequate control measures to prevent injuries to themselves and others, as well as prevent pollution to the environment.
• Monitor documentation and implementation of ISO/IEC 17025.
• Act as approved signatory for ISO/IEC 17025 on environmental testing.

Requirements

• Bachelor's degree in a 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 skills.
• 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 have knowledge on ISO 14644, ISO 17141, ISO 11737, and ANSI/AAMI-ST72.
• Experience in Quality Assurance or medical device/manufacturing environment would be an advantage.
• Proficient in relevant Microsoft Office applications.
• Preferably have experience in QMS audit/internal audit/supplier audit in the context of ISO 13485/9001 or equivalent.
• Good analytical and problem-solving skills (FMEAs, 5-whys, 8D, etc.).