Benefits

• Be part of a supportive and stable working environment
• Working within a global team

About the company
Work within a large global Biotechnology company that boasts a good company culture that is always expanding.

About the opportunity
Reporting to the Sterility Assurance SME, the Associate / Senior Associate, Sterility Assurance will be responsible for the oversight and life cycle management of Sterility Assurance controls governance, validation controls and monitoring controls at the site.

Duties

• Report writing, trending
• Author risk assessments, protocols and reports, environmental monitoring and media fills
• Environmental and Personnel monitoring, In-process testing, finished product testing, microbiological method development
• Validation and qualification of the facility, utility and equipment, process, personnel and method at the site cleaning and disinfection, hygiene, operator training, gowning and behaviour, facility design and process design at the site
• Provide QA oversight of quality standards and systems aligned with the Sterility Assurance function in the above areas for the site
• Ability to build and maintain strong relationships and collaborate effectively with all levels and cross-functionally within the organisation

Skills and Experience

• Bachelor of Science is required for this role
• Demonstrated strong technical knowledge in the areas of sterility assurance of aseptic clean room facilities, their processes and equipment, including design, validation and monitoring, life cycle management and cGMP compliance
• Minimum +3/+5 (Associate/Senior Associate) years of experience in the pharmaceutical manufacturing industry with direct experience in sterility assurance of aseptic processing
• Extensive professional experience with respect to aseptic clean rooms, processes, equipment, validation, microbial monitoring, aseptic behaviours and gowning
• Demonstrated experience in quality assurance and regulatory compliance with GxP, FDA, EU and other regulatory agency guidelines
• Experience in the manufacturing of biologics
• Direct experience executing Quality Assurance functions and system within a manufacturing and QC Microbiology/Sterility Assurance context
• Experience in interacting with regulatory authorities including submissions and inspections

Culture
Although a large, global company, they are able to provide a family-like culture and prides itself in improving the lives of others.

Why this opportunity is right for you
This is a Full-time 12-month contract opportunity based in the Northern Suburbs of Melbourne. Work is Monday to Friday only with the majority on-site.

How to Apply
Click apply or contact Jo Turner, Senior Specialist Manager on 03 9938 7120 for a confidential discussion.