The Opportunity

It began with a promise. CSL, was formed more than 100 years ago to save lives using the latest technologies. In the century since, CSL has grown into a global biotechnology leader, driven by that same promise to save and improve lives by offering the broadest range of quality plasma-derived and recombinant therapies in our industry.

We are looking for a Manager to lead a team of instrumentation specialists to support laboratory instrumentation in a high-volume operational testing environment at our the Broadmeadows (Australia) site. As the Manager of the Quality Control (QC) Instrumentation team you will collaborate globally and locally to support laboratory infrastructure and ensure it complies with regulatory requirements and CSL procedures.

The Role

Reporting to the Associate Director, Head of QC Excellence who is based in Bern (Switzerland), you will:

• Qualify, calibrate and maintain laboratory instrumentation and equipment following policies and procedures and GxP requirements;
• Support the qualification, validation and lifecycle management of existing and newly implemented laboratory automation systems applications in collaboration with Engineering and I&T departments;
• Maintain working knowledge of regulations and guidelines for laboratory instrumentation and computerized systems (i.e. USP, 21CFR Part 11, Annex 11 regulations) to ensure compliance with guidelines and industry best practice;
• Support users in operational QC labs on instrumentation and equipment by establishing instrument operation and maintenance procedures, providing technical support and coordinating repairs and support through external providers;
• Ensure documentation for laboratory instrumentation and process automation projects follow CSL documentation and data integrity requirements;
• Represent QC in regulatory inspections as related to instrumentation, automation and equipment qualification and lifecycle activities;
• Liaise regularly with colleagues around the globe to establish and improve lean processes of instrumentation lifecycle activities with a view to harmonizing processes across the global CSL network.

Your skills and experience

To be considered for this role, you have:

• A university degree in a relevant scientific discipline (Biology, Microbiology, Chemistry);
• 5+ years' experience in a pharmaceutical/medicinal GMP testing environment using a variety of testing instrumentation; Experience in equipment qualification and lifecycle activities are advantageous;
• Knowledge of regulatory requirements regarding computerized systems and laboratory automation;
• Experience in a role requiring the resolution of complex issues and collaboration across different functions;
• Experience managing a team to complete a range of different activities following a schedule;
• Experience presenting complex information both in writing and verbally.

How to apply: Please send us your resume and covering letter (in one document), which addresses the criteria above and includes reference number R-173327 by July 12, 2022.

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!