Microbiologist

BACTIGUARD ( SOUTH EAST ASIA) SDN. BHD.; Simpang Ampat; On-site; MYR 33,000 - 67,000; Full time

Job summary

BACTIGUARD ( SOUTH EAST ASIA) SDN. BHD. a Swedish medical device company, seeks a microbiology specialist to perform sterility and microbiological testing and to support EO/Gamma sterilization validation. You will craft SOPs, ensure QA/QC, and contribute to internal audits and product release.

The role emphasizes hands-on lab work, data review, and adherence to ISO 13485 in a growing healthcare solutions company serving hospitals, pharmacies, clinics and patients.

Qualifications

• Hands-on sterility, bioburden and microbiological testing.
• Experience in developing SOPs and Work Method Statements per ISO 13485.
• Contribute to QA/QC through proficiency testing and internal audits.

Responsibilities

• Perform sterility and microbiological testing with proper documentation.
• Support EO sterilization validation and IQ/OQ/PQ of equipment.
• Prepare reports and maintain laboratory records with accuracy.
• Maintain and calibrate lab equipment.
• Develop and review SOPs and validation protocols.
• Assist in product quality review and CAPA processes.

Skills

Sterility testing

Bioburden testing

Microbiological testing

SOP development

QA/QC knowledge

Education

ISO 13485 awareness

Tools

Incubators

Autoclaves

Microscopes

Job description

Possess understanding and hands-on experience in performing sterility testing, bioburden testing, and microbiological testing.

• Support EO (Ethylene Oxide) Sterilization validation activities including IQ/OQ/PQ of machinery and equipment, routine monitoring, data review & interpretation, suggestions for improvement, problem solving and troubleshooting, understanding of operation and limitations of EO Sterilizer.
• Understanding of Gamma sterilization process and result interpretation.
• Possess hands-on experience in developing SOPs and Work Method Statements in compliance with requirements of ISO 13485.
• Preparing culture media, inoculating cultures, and maintaining appropriate laboratory conditions for microbial growth
• Documenting test results accurately and preparing detailed laboratory reports.
• Following and adhering to standard operating procedures (SOPs) and quality assurance protocols to ensure consistent and reliable results
• Maintaining laboratory equipment, including incubators, autoclaves, microscopes, and other microbiological instruments
• Assisting in the development and validation of new microbiological testing methods
• Participating in quality control and quality assurance activities including proficiency testing and internal audits.
• Manage and conduct microbiology section activity on daily routine analysis.
• Create, revise and review protocols, supporting microbiological data and reports associated with method validation, testing and release of starting materials, intermediates, finished products.
• Monitor, execute and analyse data of environmental monitoring.
• Develop, revise and review SOPs, qualification/validation protocols and reports.
• Execution of the product quality review process.
• Conduct the corrective action and preventive action system.

Bactiguard (South East Asia) Sdn. Bhd. is a Swedish medical device company with a mission to save lives. To achieve this mission, we develop and supply infection prevention solutions which reduce the risk of healthcare associated infections and the use of antibiotics. In this way, we save significant costs for healthcare and the society at large.

Join us and be part of a company that innovates and provides patented technological solutions across the healthcare industry. We are a growing company, established in providing medical device solutions with a Mission to Save Lives, from hospitals, pharmacies, clinics, and patients.

Bactiguard (South East Asia) Sdn. Bhd. is a Swedish medical device company with a mission to save lives. To achieve this mission, we develop and supply infection prevention solutions which reduce the risk of healthcare associated infections and the use of antibiotics. In this way, we save significant costs for healthcare and the society at large.

Join us and be part of a company that innovates and provides patented technological solutions across the healthcare industry. We are a growing company, established in providing medical device solutions with a Mission to Save Lives, from hospitals, pharmacies, clinics, and patients.