This is an IT support group | Microbiologist

1 day ago


Singapore This is an IT support group Full time

Job 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), providing support and guidance to other team members on non-routine microbiological testing for validation and engineering studies, and resolving operational issues.
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) comply with various regulatory requirements.
Act as approved signatory for ISO/IEC 17025.
Job Responsibilities
Perform routine/non-routine microbiological testing on raw materials, in-process samples, finished products (pre and/or post sterilization), and 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 laboratory equipment to ensure they are fit for intended usage, with proper calibration and maintenance programs established.
Ensure continuous flow of all necessary resources (e.g., supplies, trained analysts, equipment) for smooth laboratory activities.
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 training activities for newcomers and qualifying them on microbiological test methods.
Adhere to all EHS rules, regulations, and risk assessments, taking adequate control measures to prevent injuries and pollution to the environment.
Monitor documentation and implementation of ISO/IEC 17025.
Job Requirements
Bachelor's degree in a Science discipline (e.g., Pharmaceutical 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, 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 knowledgeable about ISO 14644, ISO 17141, ISO 11737, and ANSI/AAMI-ST72.
Experience in Quality Assurance or medical device/manufacturing environment is an advantage.
Proficient in relevant Microsoft Office applications.
Preferably experienced 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.).
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