Job Description

Job Title:

Microbiologist

Location:

Singapore

Industry:

Medical Devices Technology

Reporting to:

Laboratory Manager

Job Overview

We are seeking a highly skilled Microbiology Laboratory Specialist to conduct routine laboratory operations, including cleanroom environmental monitoring and product-related testing. You will be expected to be competent in your area of expertise (Environmental Monitoring or Product Testing), provide support and guidance to team members on non-routine microbiological testing, and assist in resolving operational issues. You will also assist in reviewing microbiological test data and laboratory investigations in the absence of the lab manager. Ensuring all testing elements are compliant with regulatory requirements is a must.

Key Responsibilities

Perform routine and non-routine microbiological testing on raw materials, in-process samples, finished products, and environmental monitoring according to established procedures. Perform quality checks for media used in testing and maintain masters / cultures used for testing. Implement and maintain laboratory environmental conditions. Review product/environment microbial trends, highlighting emerging trends and uncommon bacterial occurrences. Coordinate 3rd party lab microbiological testing activities (e.g., bacterial identification, endotoxins test). Qualify and maintain laboratory equipment to ensure suitability for intended use, with proper calibration and maintenance programs. Ensure a continuous flow of necessary resources (e.g., supplies, trained analysts, equipment) for smooth laboratory operations. Ensure the accuracy, integrity, traceability, and reliability of test reports and sample information. Ensure proper filing 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. Provide support for personnel 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 newcomers and qualifying them on microbiological test methods. Adhere to all EHS rules, regulations, and risk assessments. Monitor documentation and implementation of ISO/IEC 17025.

Profile of Ideal Candidate:

Bachelor's/Diploma in Science discipline (e.g., Pharmaceutical Science, Microbiology, Biological Science). At least 2-3 years of relevant experience in a laboratory environment. Experience in cleanroom and environmental control 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 the ability to work independently. Able to work under pressure and deliver within work schedules. Knowledgeable of applicable standards such as ISO 13485, ISO/IEC 17025, preferably with knowledge of ISO14644, ISO17141, ISO11737, and ANSI/AAMI-ST72. Experience in Quality Assurance or a medical device/manufacturing environment is an advantage. Relevant Microsoft Office Applications skills. Experience in QMS audits, internal audits, and supplier audits within the context of ISO 13485/9001 is preferred. Good analytical and problem-solving skills.
If you are keen to have a preliminary chat, please send your CV directly to gabriel@adabagroup.com


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