The Opportunity

Established over a century ago, CSL comprises businesses with long standing, specialised expertise delivering a healthier today and a better tomorrow for patients and people everywhere. CSL Behring is a global biotech leader with a broad range of biotherapies for rare and serious diseases including bleeding disorders and immunodeficiencies.

We have opportunities for Scientist to join our Quality Control Excellence Instrumentation team on approximately18 months fixed term role working on QC laboratory instrument Qualification at the Broadmeadows site

Reporting to the Manager, Head of QC Excellence Instrumentation, you are the Subject Matter Expert (SME) on laboratory instrumentation, and you support process automation (electronic laboratory systems) infrastructure. You will lead local instrumentation projects and support process improvement and standardization projects on a local and global level.

The Role

In this role, you will:

• Provide colleagues with technical and scientific support on complex tasks on a local and global level and you will continue to improve relationship within Quality Control and with relevant partners
• Support the planning and lead the execution of laboratory instrument qualification projects, including projects with interfaces to process automation (e.g. laboratory execution system software, LIMS).
• Author and review qualification documentation for laboratory instruments in collaboration with global and local partners (in particular Laboratory Execution Systems)
• Coordinate and perform periodic system review activities on behalf of the QC business process owner and system owner including coordinate activities with engineering functions
• Coordinate and supervise the maintenance and calibration activities for laboratory instrumentation
• Support the development and modernization of laboratory instrumentation and laboratory process automation systems by providing input into local and global investment projects
• Follow CSL documentation and data integrity requirements including maintaining standard operating procedures and other documentation in relation to laboratory instrumentation and related processes.

Your skills and experience

To be considered for this role you have:

• University degree in a relevant scientific discipline (Biology, Microbiology, Chemistry);
• 2 or more years’ experience in cGMP Quality Control with the ability to apply cGMP principles
• Experience in laboratory instrumentation lifecycle management (including qualification) and/or laboratory process automation.
• Technical skills and to perform system maintenance activities on a variety of instruments and software applications
• Experience in a role requiring prompt and effective resolution of customer queries

• Provide colleagues with technical and scientific support on complex tasks on a local and global level and you will continue to improve relationship within Quality Control and with relevant partners
• Support the planning and lead the execution of laboratory instrument qualification projects, including projects with interfaces to process automation (e.g. laboratory execution system software, LIMS).
• Author and review qualification documentation for laboratory instruments in collaboration with global and local partners (in particular Laboratory Execution Systems)
• Coordinate and perform periodic system review activities on behalf of the QC business process owner and system owner including coordinate activities with engineering functions
• Coordinate and supervise the maintenance and calibration activities for laboratory instrumentation
• Support the development and modernization of laboratory instrumentation and laboratory process automation systems by providing input into local and global investment projects
• Follow CSL documentation and data integrity requirements including maintaining standard operating procedures and other documentation in relation to laboratory instrumentation and related processes.

• Technical skills and to perform system maintenance activities on a variety of instruments and software applications
• Experience in a role requiring prompt and effective resolution of customer queries

• University degree in a relevant scientific discipline (Biology, Microbiology, Chemistry);
• 2 or more years’ experience in cGMP Quality Control with the ability to apply cGMP principles
• Experience in laboratory instrumentation lifecycle management (including qualification) and/or laboratory process automation.