Senior Sterility Assurance Specialist

The Opportunity:

We are looking for Senior Sterility Assurance Specialist to join our Sterility Assurance team at CSL Behring. You will be responsible for prioritisation, organisation and communication of workload and issues/resolutions through appropriate forums and representation of topics on local levels. You will work in close collaboration with the local function and most complex Value Streams, and site leadership team, develop strategies to ensure adherence to regulatory and CSL standards related to Sterility assurance governance and drive improvements. You will provide oversight of quality standards and systems aligned with the Sterility Assurance standards for the dedicated Value Stream area site.

This will be a permanent opportunity based at our Broadmeadows site.

The Role:

Reporting into the Site or Regional Lead of Sterility Assurance, you will:

• Provide strategic leadership to the site engineering, validation, operations and quality functions related to sterility assurance.
• Collaborate with the local SA, quality and manufacturing teams to provide a holistic contamination control strategy and improvement plan at the CSL Enterprise Manufacturing site.
• Support development of sterility assurance standards and processes consistent with global governance, regulatory requirements and industry standards (quality systems, policies, procedures and work instructions).
• Support quality systems related to Validation, LIMS, Calibration, Document Management, Deviation Management, CAPA, Change Control and Enterprise Learning Management and ensure compliance with company standards and GMP regulatory guidelines.
• Write and manage validation plans, ensuring appropriate, validation/revalidation is maintained.
• Conduct internal audits and assist with 3rd party quality audit; plans and implement continuous improvement projects.
• Provide expert input to deviation investigation in the area of aseptic filling and lyophilization, sterile filtration media fill, environmental monitoring, aseptic training and bioburden test fail.
• Collaborate to resolve technical issues, provide quality training and communicate best practices.

Your Experience:

• Demonstrated technical knowledge in sterility assurance of aseptic cleanroom facilities, their processes and equipment, to include design, validation and monitoring, life cycle management and cGMP compliance.
• 5+ years of experience in the pharmaceutical manufacturing industry with experience in sterility assurance of aseptic processing
• Experience in Quality Risk Management and working in multidiscipline teams on aseptic cleanrooms, process, equipment, consumables and utilities, validation and microbiological monitoring.
• Experience implementing Quality Assurance function and system within a manufacturing and QC Microbiology/Sterility Assurance context.

How to Apply?

Please apply with your resume and cover letter outlining the key selection criteria, applications close by 20 November 2024. Apply now to join a world-class pharmaceutical organisation that is continuing to grow and with a high-achieving, positive and diverse team!

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Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring .

We want CSL to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL Behring!