Senior Microbiologist

Junee Southern Cross; Sydney; On-site; AUD 120,000 - 150,000; Full time

Benefits offered by this job

Learning culture with in-housetraining

Birthday and volunteer leave

Annual leave purchase scheme

Private health care discount

Employee assistance program

Novated leasing

EV charging bays at Marsden Park headh

Job summary

Medline is seeking a Senior Microbiologist to lead microbiological control, environmental monitoring and sterility assurance programs for safe, compliant products. You will serve as the site SME for microbiology, provide risk-based technical guidance, and drive continuous improvement across testing and contamination control.

Responsibilities include leading investigations, validating methods, supporting change controls, and partnering with Quality, Manufacturing and Regulatory teams to ensure

Qualifications

• Degree in Microbiology or related field with 5+ years in regulated GMP environments.
• Strong knowledge of TGA, GMP and quality systems; ISO 13485, ISO 14644, ISO 11737 familiarity.
• Ability to interpret complex microbiology data and provide evidence-based recommendations.
• Proactive, hands-on approach with ownership and problem solving.

Responsibilities

• Act as site SME for microbiology, contamination control and sterility assurance.
• Own microbiological testing and monitoring activities including bioburden and environmental monitoring.
• Monitor and trend data to identify risks and improve contamination controls.
• Lead investigations into microbiological excursions and non-conformances with corrective actions.
• Support validation and revalidation of cleaning, test methods and sterilisation activities.
• Provide microbiology input to new products, change controls and risk assessments.
• Oversee external microbiology labs and ensure testing quality.
• Develop and maintain microbiology procedures and audit-ready documentation.
• Collaborate with Quality, Manufacturing and Regulatory teams during audits and inspections.
• Drive continuous improvement across microbiological testing and contamination control.

Skills

Microbiology

Environmental Monitoring

Sterility Assurance

Investigations

Documentation

Education

Microbiology degree

Job description

Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care. Through its broad portfolio, resilient supply chain and leading clinical solution, Medline helps healthcare providers improve their clinical, financial and operational outcomes. Our culture is built on relentless customer focus, a drive to succeed, and the belief that relationships matter. We're gritty problem solvers who value transparency and show agility and flexibility in everything we do. To learn more about how Medline makes healthcare run better, visit www.medline.com.au

About the Role

The Senior Microbiologist provides technical leadership and oversight of Medline's microbiological control, environmental monitoring and sterility assurance programs to support the manufacture of safe, compliant and high-quality products. The role acts as the site subject matter expert for microbiology and contamination control, providing risk-based technical advice, leading microbiological investigations and validation activities, and ensuring programs remain effective, scientifically justified and aligned with applicable regulatory, ISO, quality system and business requirements.

Job Description

The Senior Microbiologist provides technical leadership and oversight of Medline's microbiological control, environmental monitoring and sterility assurance programs to support the manufacture of safe, compliant and high-quality products. The role acts as the site subject matter expert for microbiology and contamination control, providing risk-based technical advice, leading microbiological investigations and validation activities, and ensuring programs remain effective, scientifically justified and aligned with applicable regulatory, ISO, quality system and business requirements.

• 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.

Knowledge / Skills / Abilities:

• 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.

#LI-AUS

What We Offer

• Learning culture with dedicated in-house training and study assistance
• Enjoy 1 day of birthday leave and volunteer leave per year
• Purchase additional annual leave scheme
• Private health care discount with BUPA
• Free partnership with Sonder - a leader in medical, mental health and safety employee assistance 24 hours a day, 7 days a week
• Novated leasing
• Free EV charging bays for employees based in Marsden Park head office

Belonging at Medline

We're dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best.