Senior Microbiologist

About the role

Medline, a provider of medical-surgical products and supply chain solutions, is hiring a Senior Microbiologist. The role provides technical leadership and oversight of microbiological control, environmental monitoring and sterility assurance programs that support the manufacture of safe, compliant and high-quality products. It acts as the site subject matter expert for microbiology and contamination control.

Key responsibilities

• Own and deliver microbiological testing and monitoring, including bioburden testing, environmental monitoring and review of results
• Monitor and trend microbiological and cleanroom data to spot emerging risks and adverse trends
• Lead investigations into microbiological excursions, atypical results and non-conformances, with risk-based recommendations and corrective actions
• Support validation and revalidation, including cleaning validation, microbiological test methods and sterilisation-related activities
• Provide microbiology expertise for new products, change controls, risk assessments and changes to processes, facilities, equipment and suppliers
• Oversee external microbiology laboratories and testing providers
• Develop and maintain microbiology procedures, protocols, reports and technical documentation
• Partner with Quality, Manufacturing and Regulatory teams, giving technical guidance and training during audits
• Drive continuous improvement across microbiological testing, environmental monitoring and contamination control

Required profile

• Degree in Microbiology, Biomedical Science, Biological Sciences or a related discipline
• At least 5 years' relevant microbiology experience in a regulated medical device, pharmaceutical, healthcare or GMP/TGA manufacturing environment
• Strong knowledge of TGA, GMP and quality management system requirements, including ISO 13485, ISO 14644 and ISO 11737
• Ability to interpret complex microbiological data and give clear, evidence-based recommendations

What we offer

• In-house training and study assistance
• One day of birthday leave and one day of volunteer leave per year
• Option to purchase additional annual leave
• Private health care discount with BUPA
• Employee assistance program partnership with Sonder
• Novated leasing
• Free EV charging bays for employees at the Marsden Park head office