Total 2 microbiologist job vacancies in D22 Jurong, Jurong Island, Tuas

Job 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 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 sterilize), as well as environmental monitoring according to WI
• 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 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
• 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.

Job Requirements

• Bachelor 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…)

Administered by the Workforce Advancement Federation (WAF), the Career Conversion Programme (CCP) for Biomedical Manufacturing Executives is a premier talent development initiative designed to cultivate the next generation of skilled professionals for Singapore’s Biomedical manufacturing industry. This comprehensive 15-month programme features structured on-the-job training (OJT) provided at Novartis Singapore Pharmaceutical Manufacturing Pte Ltd (NSPM), facilitating the practical application of acquired knowledge and ensuring participants develop the essential competencies required for their roles.

Eligilibity for CCP:

• Singapore Citizen or Permanent Resident;

• Minimum 21 years old;

• Mid-Career Individual: Graduated, or completed National Service, whichever is later, for at least 2 years* prior at the point of application; or

• Fresh Graduate: Graduated, or completed National Service, whichever is later;

• Not in a similar job function prior to joining Career Conversion Programme (CCP);

• Have not attended the same programme – Career Conversion Programme (CCP) for Biomedical Manufacturing Executives / Professionals (Train-and-Place with Commitment to hire) – previously;

• Have not been funded under the same programme – Career Conversion Programme (CCP) for Biomedical Manufacturing Executives / Professionals (Train-and-Place with Commitment to hire) – previously.

• Should not be shareholders, immediate ex-employees of Novartis, or be related to shareholders of Novartis.

Successful candidates must be able to commence the program by March 2025.

Job Purpose

Support all activities establishing and maintaining Microbiology lab in BioProduction Operations QC. Ensure all microbiological testing of samples for production support and documented in accordance with written testing SOP’s and in accordance with local and/or international regulations.

Key Responsibilities

• Maintain QC Micro/EM laboratory in full cGMP-compliance.

• Track and execute individual training requirements to ensure completion on time including new methods and instrumentation.

• Ensure laboratory operations are in accordance to cGMP standards

• Perform microbiological testing and EM sampling in accordance current testing monographs/SOPs and in accordance with local/ international regulations.

• Ensures that testing completed in a timely manner based on plan.

• Support laboratory routine operations such as inventory management and house-keepings.

• Support the optimization of work flows in the QC Micro/EM Laboratory.

Requirements

•Minimum Diploma with 4 to 5 years of relevant working experience, preferably in a cGMP environment. Fresh graduates are welcome to apply.

• New entrants to biopharmaceutical industry and should not be holding a bond obligation with any organisation

• Related experience should be in GMP-regulated industries in Quality Control

• Background knowledge on analysis such as Bioburden and Endotoxin testing

• Preferrably a working knowledge of FDA and ex-USA regulatory requirements as well as industry quality management tools, standard, and quality systems.