Senior Microbiologist: Contamination & Sterility Leader

Medline Industries, LP; Sydney; Sur place; AUD 120 000 - 170 000; Plein temps

Avantages offerts par ce poste

Birthday leave

Volunteer leave

Annual leave purchase

Private health care discount

Employee assistance program

Novated leasing

EV charging bays

Résumé du poste

Medline Industries, LP is seeking a Senior Microbiologist to provide technical leadership for microbiological control, environmental monitoring and sterility assurance across manufacturing. You will act as the site SME, lead microbiological investigations, and ensure compliance with regulatory and ISO requirements.

You will own testing and monitoring, trend data, lead corrective actions, and contribute to validation activities while collaborating with Quality, Manufacturing and Regulatory teams

Qualifications

• Degree in Microbiology or a related discipline with relevant regulatory manufacturing experience.
• At least 5 years of microbiology experience in GMP/TGA/regulated environments.
• Strong knowledge of ISO 13485, ISO 14644 and ISO 11737.
• Ability to lead investigations and provide evidence-based recommendations.

Responsabilités

• Act as site SME for microbiology, contamination control and sterility.
• Own microbiological testing and monitoring activities including bioburden and environmental data.
• Lead investigations into excursions and non-conformances with risk-based actions.
• Support validation/reenvalidation activities for cleaning and methods.
• Provide microbiology input into new products, changes, and risk assessments.
• Oversee external labs to ensure testing quality and timely reporting.
• Develop microbiology procedures, reports and audit-ready documentation.
• Guide cross-functional teams during audits and inspections.

Connaissances

Microbiology degree

Regulatory awareness

Analytical thinking

Risk assessment

Technical leadership

Investigations

Formation

Bachelor in Microbiology

Description du poste

Medline Industries, LP is seeking a Senior Microbiologist to provide technical leadership for microbiological control, environmental monitoring and sterility assurance across manufacturing. You will act as the site SME, lead microbiological investigations, and ensure compliance with regulatory and ISO requirements.

You will own testing and monitoring, trend data, lead corrective actions, and contribute to validation activities while collaborating with Quality, Manufacturing and Regulatory teams