20 Oct
|
Medline
|
Sydney
About the Role
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
Job Description
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 current 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 *****, ISO ***** and ISO *****.
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.
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.
#J-*****-Ljbffr
📌 Senior Microbiologist (Sydney)
🏢 Medline
📍 Sydney