Senior Microbiologist – Contamination Control & Compliance

Medline; Australia; On-site; AUD 120,000 - 170,000; Full time

Benefits offered by this job

Birthday leave option

Annual leave benefit

Private health care discount

Job summary

Medline is seeking a Senior Microbiologist to provide technical leadership and oversight of microbiological control, environmental monitoring and sterility assurance programs supporting safe, compliant, high-quality products.

The role acts as the site SME for microbiology and contamination control, delivering risk-based technical advice, leading investigations and ensuring programs align with regulatory, ISO, quality system and business requirements.

Qualifications

• A degree in Microbiology, Biomedical Science, Biological Sciences or a related discipline, with at least 5 years' relevant microbiology experience in a regulated medical device, pharmaceutical, healthcare or GMP/TGA manufacturing environment.
• Commercial awareness and sound judgement, with the ability to understand operational realities and develop proportionate, practical solutions while maintaining appropriate quality and regulatory standards.
• Strong knowledge of relevant TGA, GMP and quality management system requirements, with familiarity with standards such as ISO 13485, ISO 14644 and ISO 11737.
• The confidence to interpret complex microbiological information, assess its significance and provide clear, evidence-based recommendations to the business.
• A proactive, hands-on approach, with the confidence to take ownership of issues and drive them through to resolution.

Responsibilities

• Act as the site subject matter expert for microbiology, contamination control, environmental monitoring and microbiological aspects of sterility assurance.
• Own and deliver microbiological testing and monitoring activities, including bioburden testing, environmental monitoring and review of microbiological results.
• Monitor and trend microbiological and cleanroom data to identify emerging risks, adverse trends and opportunities to strengthen contamination controls.
• Lead investigations into microbiological excursions, atypical results and non-conformances, providing practical, risk-based recommendations and corrective actions.
• Support validation and revalidation activities, including cleaning validation, microbiological test methods and sterilisation-related activities.
• Provide microbiology expertise into new products, change controls, risk assessments and changes to manufacturing processes, facilities, equipment and suppliers.
• Oversee external microbiology laboratories and testing providers, ensuring appropriate technical standards and quality of testing and reporting.
• Develop and maintain microbiology procedures, protocols, reports and technical documentation, ensuring programs remain compliant and audit-ready.
• Partner with Quality, Manufacturing and Regulatory teams, providing technical guidance, training and support during internal, external and regulatory audits.
• Drive continuous improvement across microbiological testing, environmental monitoring and contamination control programs.

Skills

Microbiology knowledge

Environmental monitoring

Sterility assurance

Education

Bachelor's degree in Microbiology or related field

Tools

ISO 13485 familiarity

GMP awareness

Job description

Medline is seeking a Senior Microbiologist to provide technical leadership and oversight of microbiological control, environmental monitoring and sterility assurance programs supporting safe, compliant, high-quality products.

The role acts as the site SME for microbiology and contamination control, delivering risk-based technical advice, leading investigations and ensuring programs align with regulatory, ISO, quality system and business requirements.