Senior Microbiologist - Contamination & Sterility Lead

Medline Industries; New South Wales; Vor Ort; AUD 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

Birthday leave

Volunteer leave

Private health care discount

Novated leasing

EV charging bays

Zusammenfassung

Medline Industries is seeking an experienced Senior Microbiologist to lead microbiological control, environmental monitoring and sterility assurance programs across manufacturing operations. You will act as the site SME for microbiology and contamination control, delivering risk-based technical guidance and investigations.

The role requires ownership of testing activities, trend analysis, and collaboration with Quality, Manufacturing and Regulatory teams to support audits and continuous

Qualifikationen

• Degree in Microbiology, Biomedical Science or related field.
• At least 5 years’ microbiology experience in a regulated environment.
• Knowledge of TGA, GMP and ISO standards (13485/14644/11737).
• Ability to interpret complex microbiological data and communicate findings clearly.

Aufgaben

• Own and deliver microbiological testing and monitoring activities.
• Lead investigations into microbiological excursions, atypical results and non-conformances.
• Support validation and revalidation activities including cleaning validation and sterilisation-related work.
• Provide microbiology expertise for new products, change controls and manufacturing changes.
• Oversee external microbiology laboratories and testing providers; ensure quality and reporting.

Kenntnisse

Microbiology expertise

Regulatory knowledge

Investigation leadership

Environmental monitoring

Sterility assurance

Ausbildung

Bachelor's or higher in Microbiology or related

Jobbeschreibung

Medline Industries is seeking an experienced Senior Microbiologist to lead microbiological control, environmental monitoring and sterility assurance programs across manufacturing operations. You will act as the site SME for microbiology and contamination control, delivering risk-based technical guidance and investigations.

The role requires ownership of testing activities, trend analysis, and collaboration with Quality, Manufacturing and Regulatory teams to support audits and continuous