Senior Microbiologist

Summary

The Microbiologist is responsible for establishing and maintaining the microbiological quality systems supporting the startup, qualification, validation, and routine operation of Balance Medical Singapore's Class III implantable medical device manufacturing facility.

The role will lead the development of microbiology related Quality Management System (QMS) documents, contamination control strategies, environmental monitoring programs, cleanroom microbiological qualification, sterility assurance activities, water system monitoring, and microbiological laboratory operations to ensure compliance with ISO 13485, FDA QMSR, EU MDR, ISO 11737,ISO 22442, ISO 14971, and other applicable regulatory requirements.

Responsibilities

· Establish and execute cleanroom Environmental Monitoring Program for ISO 7 / ISO 8 areas – viable and non-viable particle monitoring, personnel monitoring, trending and alert/action limit management per ISO 14644

· Lead bioburden and bacterial endotoxin (LAL) testing activities, including sampling plan development, method suitability studies, sterilization validation support, dose audits, and ongoing microbiological monitoring

· Lead chemical residue validation for Glutaraldehyde / Formaldehyde – method development with external lab, residual limits per ISO 10993-17, safety assessment

· Support animal tissue controls per ISO 22442-1/2/3 – incoming tissue bioburden, viral inactivation validation support, supplier herd documentation review

· Manage aseptic process validation, gowning qualification, and cleanroom disinfection efficacy / sporicidal validation

· Investigate microbiology deviations, OOS, EM excursions – root cause, CAPA, impact assessment to product sterility

· Prepare microbiology sections for DHF, DMR and FDA 510(k) / PMA – sterilization, shelf-life, packaging integrity

· Manage external microbiology labs – qualification, test method transfer, COA review

· Support NEA requirements for biological waste and toxic chemical waste handling

Requirements

· Bachelor / Master in Microbiology, Biology, or related discipline

· More than 5 years’ experience in medical device or pharma GMP cleanroom microbiology. Animal tissue / pericardium experience preferred

· Hands-on knowledge of ISO 13485, ISO 11737-1/2, ISO14160, ISO 14698, ISO 10993-7, ISO 22442

· Experience with EM, LAL, bioburden, sterilization validation – Autoclave, EO, E-beam and Gamma

· Experience with FDA / EU MDR submission documentation preferred

· Strong documentation, data trending, root cause investigation, and technical report writing skills, with the ability to work independently in a startup environment, establish new systems and procedures, and drive continuous improvement.