Quality Control Microbiologist

Coalesce Management Consulting; Singapore; On-site; SGD 52,000 - 78,000; Full time

Job summary

Coalesce Management Consulting is seeking a Microbiologist to perform microbiological testing, environmental monitoring and quality control activities in line with cGMP, safety and regulatory requirements. The role supports routine manufacturing operations, product release, validation, cleanroom qualification and overall microbiological compliance across the site. You will work with Quality, Operations and Engineering to deliver accurate results and documentation.

Qualifications

• Bachelor's degree in Microbiology, Biological Sciences, General Science, Engineering or a related discipline.
• Solid understanding of cGMP requirements and laboratory safety practices.
• Knowledge of microbiological laboratory techniques and aseptic practices.
• Experience with environmental and utility monitoring in regulated manufacturing environments.

Responsibilities

• Perform routine microbiological testing including sterility and endotoxin.
• Conduct environmental monitoring of cleanrooms and production areas.
• Sample utility systems (PW, WFI, steam, compressed air, nitrogen) for microbiology.
• Identify bacteria, mould and yeast from various samples.
• Maintain microbial cultures and perform growth promotion checks.
• Support qualification, requalification and validation activities.
• Prepare SOPs, protocols and test reports.

Skills

Microbiology

Environmental monitoring

cGMP knowledge

Laboratory safety

Documentation

Cross-functional teamwork

Independent work

Education

Bachelor's degree in Microbiology or related

Job description

We are looking for a Microbiologist to be responsible for performing microbiological testing, environmental and utility monitoring, and quality control activities in accordance with cGMP, safety, and regulatory requirements. The role supports routine manufacturing operations, product release, validation activities, cleanroom qualification, and overall microbiological compliance across the site.

Key Responsibilities

• Perform routine and non-routine microbiological testing, including Sterility, Bacterial Endotoxin, Bioburden and Microbial Limits Testing.
• Conduct environmental monitoring of cleanrooms, production areas and laboratories, including particle monitoring.
• Perform microbiological monitoring and sampling of utility systems including Purified Water, WFI, Pure Steam, Compressed Air and Nitrogen.
• Perform microbial identification of bacteria, mould and yeast from environmental, water and product samples.
• Conduct media sterility checks, Growth Promotion Testing and maintenance of microbial cultures.
• Support personnel, cleanroom and plant qualification/requalification and validation activities.
• Prepare and review microbiology-related documentation including SOPs, protocols and test reports.
• Coordinate laboratory equipment calibration, maintenance and validation with vendors and service providers.
• Maintain laboratory consumables and coordinate with relevant suppliers.
• Work closely with Quality, Operations, Engineering, Projects and other departments to provide microbiological and technical support.
• Ensure all activities comply with cGMP, SHE and applicable quality requirements.
• Perform other duties as assigned by the Supervisor or Manager.

Qualifications

• Bachelor's Degree in Microbiology, Biological Sciences, General Science, Engineering, or a related discipline.
• Good understanding of cGMP requirements and laboratory safety practices.
• Knowledge of microbiological laboratory techniques and aseptic practices.
• Good understanding of environmental and utility monitoring within a pharmaceutical or regulated manufacturing environment.
• Strong attention to detail and ability to maintain accurate laboratory documentation.
• Good written and verbal communication skills.
• Ability to work effectively with cross-functional teams, external vendors, and service providers.
• Ability to work independently while adhering to established procedures, quality standards, and regulatory requirements.