Total 8 Others/Any 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.

Reporting to QC Manager

Responsibilities:

• Collect routine and non-routine Environmental Monitoring Samples (EMP) onsite at manufacturing area including swab, air samples and water samples.
• Carry out the microbiological testing activities for the EMP samples including media preparation, testing, waste disposal and cleaning. If needed, to support the product testing.
• Ensure the plant EMP is followed to the agreed sampling schedule and escalate any abnormal results and observations during sample collection to lab manager and plant hygienist timely. Proficient to use GLIMS to manage the laboratory data recording and retrieve data to support the data trending and investigation purpose.
• Maintain the EMP results record in good documentation manner so that they are easy to retrieve. Trend the EMP results for all the testing parameters routinely.
• Be able to support the urgent business need by doing sampling or testing over the time or at weekend where is required.
• Ability to stay organized and multitask in a high volume, fast passed work environment.
• Work independently to ensure the assigned task for samples are tested in a timely manner to meet TAT, according to established test methods, technology and quality requirements to provide accurate results.
• Good understanding of GLP, GDP and GMP for working in laboratory and production plant.
• Ensure the current, complete, legible notebooks and laboratory records are maintained in compliance with good laboratory practices.
• Good knowledge in lean lab concept and actively involve or lead the continuous improvement project to improve the laboratory test efficiency and productivity. Understand the root cause analysis tool and apply to the problem solving and investigation.
• Look after the good inventory of QC materials such as media, reagents, chemicals and consumables to support testing.
• Proactively lead and maintain the housekeeping standard of laboratory, work area and equipment (e.g. practice 5S), observe safety requirements and Good Laboratory Practice in the laboratory which is compliant with company and regulatory standards.

Requirements:

• Degree holder in Microbiology, food science or related with at least 2 years, preferably in milk powder or similar manufacturing plant.
• Physically fit and good personnel hygiene.
• Hands on experience on microbiology laboratory testing technology and instruments such as MDS, autoclave, Vitek, Vidas etc.

Job Description

• Perform quality control microbiological testing of raw materials, intermediates, and finished products to ensure compliance with specifications and standards.
• Ensure timely testing of production environmental monitoring and production water quality.
• Perform microbiology testing data trending and escalate any adverse trends accordingly.
• Conduct investigation on out of specifications, deviation from regular and/or any other Non-Conformance Investigation related to microbiology and carry out literature research when required.
• Support equipment qualification, perform and coordinate calibration, and maintenance of microbiology laboratory equipment.
• Proactively support in continuous improvements of microbiology functions and participating in writing/revising SOPs and protocols.
• Manage the overall status of sample lab and R&D samples by performing sensory, physical and analytical testing procedures with creation of specification.
• Oversee and maintenance of Retained Sample Management.
• Ensure proper functioning and running of QC laboratories (Chemical, sensory, microbiology, retain sample room) in accordance with ISO9001, 5S, lean principle, ISO14000 and OSHAS 18001 standards and procedures.

Qualifications

• Minimum Diploma or Degree in Microbiology, Biology or equivalent in years of similar experience
• Overall work experience of at least 5 years in a similar position.
• Proficient in methods and practices of microbiological techniques and environmental monitoring
• Knowledge in standards and global regulatory requirements applicable to microbiology and environmental monitoring in biologics.
• Effective interpersonal attributes at all internal and external levels.
• Good time management and project management skills

Purpose

Act as the site microbiology subject matter expert; provide microbiologist expertise and develop monitoring strategy and operation framework.

Ensure that all site utilities, water, environmental monitoring and product testing activities are properly analysed and executed, and the results recorded in full compliance with current Good Manufacturing Practice (cGMP) and regulatory requirements that meet the defined quality standards.

Responsibilities

• Ensures that all water, environmental monitoring, site utilities and product testing samples are analysed and tested according to the stipulated quality requirements so as to provide accurate test results for correct usage decisions. Develops a strategy for the site with respect to environmental monitoring and water systems. Perform microbiological risk assessment for all non-sterile products.
• Work with relevant functions to support method validation / verification for micro related methods, ensuring that the activities are carried out in accordance to the required standards and procedures.
• Ensures that external service providers and suppliers for microbiology laboratory are managed in accordance to GSK requirements.
• Contribute to the formulation and development of the operational framework of the labs (framework covers testing protocol, SOP, and other operational policies, procedures and guidelines), and implement the approved plan.
• Contribute and occasionally lead site and corporate projects in line with specifications and budget allocation.
• Ensure a safe working environment for the laboratory and perform 5S and Zoning inspection.
• Supervise, develop, and motivate assigned analysts to help realize their maximum potential so as to contribute towards achieving the objectives of the department.
• Ensure regulatory compliance, perform L1 audit and support L2/L3/L4 audit as Microbiology Subject Matter Expert (SME).
• Ensure timeliness and accuracy of the Compliance review of Pharmacopoeia & ATS and to ensure In place and In use of the Pharmacopoeia / ATS / QMS requirement.
• Lead or participate in investigation arising from micro related and utilities investigation, incidents and accurately assess the impact of the failure so as to make appropriate recommendations on remedial actions for follow-up.
• Work with the relevant R&D groups to support micro related activities and micro risk assessment for New Product Introduction, ensuring that the activities are carried out in accordance to the required standards and procedures.
• Work closely with external staff and at line level to enable the localization and transfer of technology / knowledge / methodologies into standard order fulfillment activities.

Knowledge, Skills, and Experience

• Min degree in microbiology, chemistry, or life sciences
• Min 3 years of experience in an analytical environment in pharmaceutical or life sciences industry
• Experience in GMP
• Basic knowledge and on-going awareness of regulatory requirements (includes safety) on controlled environment and water system
• Very good knowledge of microbiological test methods
• Good knowledge of manufacturing processes and plant layouts of GlaxoSmithKline Manufacturing
• Good communication skills
• Basic financial management skills
• People Management skills

To learn more about Singapore GSK and our people, please click on this link: https://www.linkedin.com/company/glaxosmithkline/life/gsksingapore

#Li-GSK

Why Us?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. ​

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.​

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Purpose

Act as the site microbiology subject matter expert; provide microbiologist expertise and develop monitoring strategy and operation framework.

Ensure that all site utilities, water, environmental monitoring and product testing activities are properly analysed and executed, and the results recorded in full compliance with current Good Manufacturing Practice (cGMP) and regulatory requirements that meet the defined quality standards.

Responsibilities

• Ensures that all water, environmental monitoring, site utilities and product testing samples are analysed and tested according to the stipulated quality requirements so as to provide accurate test results for correct usage decisions. Develops a strategy for the site with respect to environmental monitoring and water systems. Perform microbiological risk assessment for all non-sterile products.
• Work with relevant functions to support method validation / verification for micro related methods, ensuring that the activities are carried out in accordance to the required standards and procedures.
• Ensures that external service providers and suppliers for microbiology laboratory are managed in accordance to GSK requirements.
• Contribute to the formulation and development of the operational framework of the labs (framework covers testing protocol, SOP, and other operational policies, procedures and guidelines), and implement the approved plan.
• Contribute and occasionally lead site and corporate projects in line with specifications and budget allocation.
• Ensure a safe working environment for the laboratory and perform 5S and Zoning inspection.
• Supervise, develop, and motivate assigned analysts to help realize their maximum potential so as to contribute towards achieving the objectives of the department.
• Ensure regulatory compliance, perform L1 audit and support L2/L3/L4 audit as Microbiology Subject Matter Expert (SME).
• Ensure timeliness and accuracy of the Compliance review of Pharmacopoeia & ATS and to ensure In place and In use of the Pharmacopoeia / ATS / QMS requirement.
• Lead or participate in investigation arising from micro related and utilities investigation, incidents and accurately assess the impact of the failure so as to make appropriate recommendations on remedial actions for follow-up.
• Work with the relevant R&D groups to support micro related activities and micro risk assessment for New Product Introduction, ensuring that the activities are carried out in accordance to the required standards and procedures.
• Work closely with external staff and at line level to enable the localization and transfer of technology / knowledge / methodologies into standard order fulfillment activities.

Knowledge, Skills, and Experience

• Min degree in microbiology, chemistry, or life sciences
• Min 3 years of experience in an analytical environment in pharmaceutical or life sciences industry
• Experience in GMP
• Basic knowledge and on-going awareness of regulatory requirements (includes safety) on controlled environment and water system
• Very good knowledge of microbiological test methods
• Good knowledge of manufacturing processes and plant layouts of GlaxoSmithKline Manufacturing
• Good communication skills
• Basic financial management skills
• People Management skills

To learn more about Singapore GSK and our people, please click on this link: https://www.linkedin.com/company/glaxosmithkline/life/gsksingapore

#Li-GSK

Why Us?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. ​

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.​

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Key Responsibilities:

• Manage a team of Technical Executives to provide microbiological and biological testing services to ensure successful performance and timely delivery of the study results
• Review test data and prepare test reports
• Develop and validate new test methodologies
• Interface with customers on sample submissions, job status as well as their enquiries and quotations
• Ensure compliance with laboratory quality management and safety guidelines
• Oversee the proper upkeep and maintenance of test equipment and instruments
• Other laboratory tasks as assigned by the Supervisor

Key Requirements:

• Degree in Microbiology, Biological Sciences or related disciplines
• Prior experience working in Microbiological Testing laboratories will be advantageous
• Familiarity with ISO 17025 quality management system and OECD GLP quality system would be advantageous
• Results and service-oriented individual who possesses initiative and good communication skills
• A proactive team player but with the ability to work independently in challenging projects and timelines
• Enthusiastic and resourceful with a "can-do" attitude

Key Responsibilities:

• Assist to manage / supervise the work of subordinate staff to provide microbiological and biological testing services to ensure successful performance and timely delivery of the study results
• Develop and validate new test methodologies
• Review test data and prepare test reports
• Handle enquiries and quotation as well as interface with customers on sample submissions, job status, technical matters
• Ensure compliance with laboratory quality management (ISO 17025, OECD GLP and GMP) and safety guidelines
• Ensure staff competency for the testing services
• Review and develop SOP
• Perform CAPA for non-conformance in laboratory
• Oversee the proper upkeep and maintenance of test equipment and instruments

Key Requirements:

• Minimum a Degree in Microbiology, Biological Sciences or related disciplines
• Preferably 3-5 years of work experience in Microbiological Testing laboratories
• Familiarity with ISO 17025 quality management system and OECD GLP & GMP quality system would be advantageous
• Results and service-oriented individual who possesses initiative and good communication skills
• A proactive team player but with the ability to work independently in challenging projects and timelines
• Enthusiastic and resourceful with a "can-do" attitude