Total 5 microbiologist job vacancies in Quality Assurance / Control category in Singapore

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.

The Opportunity

Esco Lifesciences Group, is Singapore’s most globalized life sciences company, with annual revenues close to SGD 200M and global operations in over 20 countries across North America, Europe and Asia.

Esco Aster Pte Ltd is an affiliate of Esco Lifesciences Group and was first introduced in 2017.

At Esco Aster Pte Ltd, we are a contract development and manufacturing organization founded and deeply rooted by scientists enabling fellow scientists to translate their bench work into commercially available products and services at affordable prices.

The work we do creates a remarkable and lasting impact on our world. Join us as we redefine healthcare for the current and future generations to come.

Esco Aster.

One World Biosolutions for One Health.

Who we’re looking for

Physical/Mental Requirements/Work Environment

· Ability to understand protocols, technical reports and technology transfer documents.

· Ability to understand standard operating procedures and other related documents.

· Able to commit to weekend work when needed, off in lieu will be given for work on public holidays.

· Repetitive motions due to certain laboratory techniques.

· Good Understanding of Aseptic Techniques.

· Work performed in a clean room environment wearing PPE.

· Ability to define problems, collect data, establish facts and draw conclusions.

· Ability to focus regardless of circumstances and stress induced pressure.

· Ability to take proactive approach.

· Meticulous and systematic.

· Commitment to continuous learning and staying updated with industry best practices.

· Have a strong focus on safety, quality and timeliness.

· Have strong critical thinking skills.

Job Responsibilities

· Establishment of QC procedures (drafting and reviewing QC functional SOPs including QC testing SOPs).

· Responsible for Environmental monitoring (Viable and Non-Viable) of Cleanrooms, water and gases as per SOPs.

· Responsible for the Microbiological Testing of Water/Raw Material/in-process/ finished product / stability/validation/utility samples as per approved SOPs.

· Perform GPT, Sterility Testing & Microbial Identification.

· Support Sample Management functions.

· Ensure testing support media and consumable inventory timely manner to avoid delay in testing.

· Write, review and update standard operating procedures timely manner to operate EM and Microbiology operations and to ensure that specifications are in compliance with current GMP requirements/standards.

· Maintain data integrity and appropriate traceability.

· Responsible to identify OOS/OOT/Deviation and participate in Root Cause Analysis (RCA) and recommend corrective and preventive actions as applicable.

· General lab support including housekeeping, equipment maintenance, inventory of supplies, lab supplies ordering, management of glass wares, autoclaving etc. Responsible for microbiology lab and equipment/ instrument cleanliness.

· Responsible for disposition of samples upon confirmation.

· Collaborate with other functional teams in new processes/equipment/method qualifications.

· Explore and implement new technologies for rapid release such as rapid sterility testing.

· The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor and QC Management from time to time to support GMP Facility.

Requirements

· Degree with at least 3 years or Diploma with at least 5 years of experience in QC (Microbiology and Environmental Monitoring) from a highly regulated cGMP manufacturing environment (Biologics, Pharmaceuticals & ATMPs etc).

· Candidates with experience in ATMPs (Cell & Gene) manufacturing are highly preferred but not mandatory.

· Ability to prioritize work and multitask.

· Knowledge and experience on QC laboratory operations and procedures, analytical test methods, troubleshooting and evaluation of analytical results

· Thorough knowledge and understanding of current regulatory requirements of cGMP manufacturing.

· Good knowledge and understanding of Biologics manufacturing, aseptic operations and cleanroom behavior.

· Experience cell and gene therapy operations is an added advantage.

· Demonstrated ability to supervise, train, and manage technical staff.

· Demonstrated knowledge in Quality Control operations as it relates to QC testing, method validations and QC system implementation.

· cGMP regulations and audit experience in USFDA, EU and HSA etc.

· Will be able to commit 5 working days per week in a fixed pattern.

· Excellent communication, interpersonal and organizational skills.

· Ability to speak and write in English.

Apply now by submitting a Cover Letter and CV to [email protected].

Job Impact & Requirement

The Laboratory Technician II will complete moderately complex analytical and laboratory testing in support of the food safety quality and operational teams. In this role, you will perform routine analysis of product testing and will check and monitor instrumentation performance, conduct tests and document results into databases and communicate test results.

Key Accountabilities

• Conduct routine quantitative and qualitative inspections and laboratory tests on raw materials, in process and final products independently and support more complex trials and experiments under intermediate supervision.
• Perform Environmental Monitoring - in-line swabbing, ATP swabbing and lab analysis
• Prepare medium and apparatus for microbiological analysis (environmental monitoring)
• Prepare samples and coordinate with 3rd Party Laboratory on the external microbiological laboratory testing for FGs, RMs, swab samples and as per customers’ requirements.
• Ensure compliance programs for all individual testing, which includes monitoring adherence to regulations and other procedural food safety compliance.
• Interpret and document results of tests into active databases and communicate results to internal customers as required.
• Run calibration checks, preventive maintenance tasks and simple repair to analytical instrumentation and maintain customer specifications books.
• Help develop food and feed safety, quality and regulatory culture and collaborate cross functionally to build, maintain and improve an effective food safety, quality and regulatory culture.
• Handle moderately complex clerical, administrative, technical or customer support issues under general supervision, while escalating more complex issues to appropriate staff.
• Other duties as assigned

Minimum Qualifications

• Possess technical and analytical skills in Quality Control
• Demonstrate analytical thinking and problem solving skills
• Possess a good sensory skills for product evaluation and troubleshooting
• Demonstrate ability to handle work professionally, independently and efficiently
• Possess attention to details

We are seeking for a QC Specialist to join our team to support our client in Pharceutical Industry. This is a contract role for a year subject to extention as per client's need.

Responsibilities:

• Perform microbiological analysis of raw material, GPT, ID samples according to Standard operating procedures and Test Methods
• Perform EM which includes BSC / HLFH / VLFH sampling, fingertips monitoring, compressed gases /air and water / clean steam sampling in accordance to cGMP procedures when required
• Documentation of results in accordance with cGMP
• Prepare EM trend reports, EM reports for product lot release and trend reports
• Review routine data and logbooks with supervisory audit
• General lab support including housekeeping, equipment maintenance, inventory of supplies, etc
• Problem solving of issues as well as troubleshooting of equipment
• Author or update existing SOPs, Forms and TMs as needed
• Discrepancy Owner or perform assessment of lab related discrepancies
• Involve in new equipment / methods qualification
• Participate internal and external audits and regulatory inspections
• Understanding of basic microbiological principles (bioburden, LAL, plating and counting techniques, etc) and execution of intermediate techniques (DET, AET)
• Perform equipment qualification / maintenance, liaise with external / contract lab / vendor
• Lead the continuous improvement of laboratory procedures and processes to ensure compliance to GMPs
• Comply with all client's Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable
• Engage in proactive measures to promote a positive safety culture while ensuring all applicable Safety, Health and Environment requirements are fulfilled in alignment with corporate policy and local legal requirements
• A team player and the willingness to cover other colleagues in continued support of the Micro/EM testing operations.

Requirements:

• Bachelor's Degree (Chemistry, Microbiology, Biochemistry or any Life Science related is preferred)
• Minimum 1 to 3 years' work experience in the pharmaceutical or related industry preferably QC related
• Knowledge of cGMP relevant to the pharmaceutical industry
• Able to determine when to escalate issue
• Ability to organize and plan effectively
• Good team player
• Demonstrate good verbal and written communication skills in English
• Must be comfortable with contract basis role