Job Description Summary
Perform a comprehensive range of microbiological analyses, ensuring all laboratory equipment, chemicals,
and glassware are maintained according to Good Laboratory Practice (GLP) standards and sterilization
protocols. Execute all necessary microbiological t ests and coordinate the maintenance and calibration of
laboratory equipment. Support Lab Quality Engineer in validation activities. Additionally, oversee and
manage lab inventory and maintenance tasks
Job Description
Responsible for:
- All Microbiology Lab testing and conduct them according to GLP.
- Proper documentation and recording of all test results.
- Stocking and ordering of laboratory chemicals, media and other supplies.
- Monitoring all results produced by Microbiology Lab.
- Preparing trend micro lab testing data
- Performing Gamma Dose Audit testing.
- Maintenance of lab equipment.
Comply with all local, state, federal, and BD Safety regulations, policies, and procedures including
RCRA Hazardous waste regulations.
Other duties as assigned.
Education And Experience
Working experience of minimum 7 years in the medical device or relevant industry laboratory
Preferable with Micro Lab and Sterilization experience
Experience with qualification/validation activities
Knowledge And Skills
Must be able to communicate in written and oral English and Bahasa Malaysia.
Good understanding of Biology, Chemistry and Mathematics.
Must be able to follow standard laboratory procedures.
Must be systematic and analytical.
Basic Computer skills Word, excel, PowerPoint applications.
Physical Demands
- Preparing sterilization certification release
- Preparing Quarantine shipment product - Exhibit A and verifying Quarantine Certificate - Exhibit B
and Quarantine product release - Exhibit C for shipment.
- Preparation of SOP's, limit calculation, validation protocols, preparation and execution of process
validation/qualification.
Specific Laboratory Testing
- Sterility test
- Maintenance of stock culture
- Environmental monitoring on air and work surface and water analysis
- Product bioburden
- Microorganism identification
- Bacteriostasis and fungi stasis
- Bioburden recovery test
To assist Lab Quality Engineer in dummy/PCD preparation during EO and Gamma sterilization
validation.
To assist Microbiologist in starting up new test methods and in writing test methods.
Ensure good housekeeping and 5S practice in Microbiology Lab.
To assist Lab Quality Engineer in OOS investigation of testing failures
Ensure adherence to Environmental, Safety and Health policies.
Comply with all local BD quality policies, procedures, and practices through consistent application of
sound quality assurance principles.
Required Skills
Optional Skills
Primary Work Location
MYS Kedah - Bard Kulim (Malaysia)
Additional Locations
Work Shift
MY3 Normal 8a-4.45p Group 26 (Malaysia)
