Microbiologist 2 year contract WDA

Job Description

• Based in Singapore, the regional hub for Asia Pacific (AP) and top-ranked biopharmaceutical company on the Straits Times and Statista’s list of Best Employers in Singapore for two consecutive years (2020, 2021).
• Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years.

This position reports to the Manager in the Microbiology Laboratory of Biotechnology Facility.

WHAT YOU WILL DO

Responsibilities include, but are not limited to:

• Perform routine/non-routine quality monitoring, sampling and testing of Utility systems inclusive of Purified water, Water for Injection, Pure steam, Compressed air, and Nitrogen systems.
• Perform the routine/non-routine environmental monitoring for all required plants, facilities, clean rooms, hygienic areas and labs, inclusive of particle monitoring tests.
• Perform personnel qualification and re-qualification and also lead qualification and re-qualification of the clean rooms, when necessary.
• Provide testing support to plant validation activities.
• Perform in-process and release samples testing of excipient/packaging components for the different drug products, semi-finished drug product, and drug substances (e.g., Sterility test, Bacterial endotoxin test, Bioburden test, Microbial Limits Test, etc., as appropriate).
• Perform routine and Batch related Environmental monitoring in clean rooms and other production areas and laboratory.
• Perform Media Receival, Sterility check and Growth Promotion Tests for media used for testing.
• Perform initial Quality Control check and regular QC checks on ready-to-use cultures and maintenance of cell cultures.
• Perform microbial identification (Bacteria, mold, and yeast) in water, environment, and product samples.
• Perform periodic review of closed-out Validation Document packages and Standard Operating Procedures.
• Extend documentation support to the department by participating in writing/revising of SOPs, protocols, Test reports and any other work assigned by the Senior, Lead Microbiologist, Sr/Manager, Microbiology.
• Liaise with external vendors on instrument calibration and maintenance.
• Solicit quotations of laboratory consumables.
• Maintain continuous supply of laboratory consumables.
• Participate in SHE, Business Compliance, cGMP and all other compliance-related matters, where applicable.
• Supervise and oversee Third Party Contractors, where applicable.
• Liaise with other departments for training needs and technical support.
• Liaise with vendor and service engineers/ESPs for equipment validation, calibration, and maintenance work.
• Coordinate with suppliers of microbiological media and other equipment.
• Coordinate with Quality, respective Plant operations, Projects and Engineering & Maintenance.
• Any other duties as assigned by the Supervisor/Manager.

WHAT YOU MUST HAVE

To be successful in this role, you will have:

Qualifications:

• Degree in Microbiology / Science (general) / related Engineering field

Required Skills / Experience / Competencies:

• Good understanding of Safety and cGMP practices

• Computer Literacy

• Good oral and written communication skills

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.