Senior Microbiologist - Contamination & Sterility Leader

Medline; Sydney; On-site; AUD 120,000 - 150,000; Full time

Benefits offered by this job

Birthday leave

Health care discount (BUPA)

EV charging bays at Marsden Park head‑

Job summary

Medline is seeking a microbiology expert to lead environmental monitoring, bioburden testing, and contamination control across sites in Australia. You will guide investigations, validate microbiology methods, and provide input to change controls and regulatory interactions.

The role requires a degree in microbiology or related field with 5+ years in regulated manufacturing, ISO/GMP familiarity, and a hands-on, proactive approach to continuous improvement.

Qualifications

• Bachelor-level degree in Microbiology, Biomedical Science, Biological Sciences or related discipline.
• 5+ years of microbiology experience in regulated medical device, pharmaceutical, healthcare or GMP/TGA manufacturing.
• Familiarity with ISO 13485, ISO 14644 and ISO 11737 and TGA/GMP/QMS requirements.

Responsibilities

• Act as site SME for microbiology, contamination control, environmental monitoring and sterility aspects.
• Own and deliver microbiological testing and monitoring activities including bioburden and environmental monitoring.
• Monitor and trend microbiological data to identify risks and strengthen controls.
• Lead investigations into excursions, atypical results and non-conformances with risk-based recommendations.
• Support validation, revalidation, cleaning validation, and sterilisation-related activities.
• Provide microbiology input into change controls, risk assessments, and manufacturing changes.
• Oversee external microbiology labs ensuring quality and reporting standards.
• Develop and maintain microbiology procedures, protocols and documentation.
• Collaborate with Quality, Manufacturing and Regulatory teams during audits.
• Drive continuous improvement across microbiology programs.

Skills

Regulatory knowledge

Quality systems

Data interpretation

Problem solving

Education

Bachelor's degree in Microbiology or related field

Job description

Medline is seeking a microbiology expert to lead environmental monitoring, bioburden testing, and contamination control across sites in Australia. You will guide investigations, validate microbiology methods, and provide input to change controls and regulatory interactions.

The role requires a degree in microbiology or related field with 5+ years in regulated manufacturing, ISO/GMP familiarity, and a hands-on, proactive approach to continuous improvement.