Sterilization & Microbiology Specialist | ISO 13485

BACTIGUARD ( SOUTH EAST ASIA) SDN. BHD.; Simpang Ampat; Sur place; MYR 33 000 - 67 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Sterility testing

Bioburden testing

Microbiological testing

SOP development

QA/QC knowledge

Formation

ISO 13485 awareness

Outils

Incubators

Autoclaves

Microscopes

Description du poste

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.