Job Type: Full time
Join the CSL Behring Validation team on a full-time permanent basis. CSL Behring Broadmeadows manufactures a comprehensive portfolio of 15 plasma products for Australia from plasma collected by the Lifeblood Australia. Part of the CSL family, when you join the over 1200 employees at Broadmeadows, you join an integrated global network of research and manufacturing facilities delivering on our 100-year-old promise to save lives using the latest technology.
As the Validation Lead you will manage the process and cleaning validation activities for across the CS: Behring Australia Business following the Site Validation Master Plan and validation procedures to deliver effective and compliant processes. As the Subject Matter expert, you will provide guidance to site staff for process and cleaning validation and work with across the site to ensure that validation activities are completed efficiently.
Reporting to the Process and Analytical Lifecycle Management (PALM) Site Lead, and working on site at Broadmeadows, you will:
- Manage the continued process verification activities for the CSL Behring Australia;
- Manage the extractable and leachable activities for CSL Behring Australia.
- Ensure equipment and process control have been installed adequately to allow process and cleaning validation activities to be undertaken;
- Manage the development and maintenance of the process and cleaning validation master plans for CSL Behring Australia;
- Manage the departmental documentation for process and cleaning validation activities and prepare validation concepts;
- Conduct or participate in regulatory audits, investigations for validation deviations, change control panels and perform assessment of change controls for impact on validation status;
- Lead a small team and provide support to team to upskill and focused on continuous improvements.
Skills and Experience:
To be considered for this role you must have:
- A degree in science or engineering;
- 5+ years’ experience in the pharmaceutical manufacturing industry in a cGMP environment with experience in Process and Cleaning Validation;
- Knowledge of cGMP including industry guidance documents and standards relating to validation;
- Experience leading a technical team in a regulated environment
- Experience in pharmaceutical industry regulatory requirements including TGA & FDA audits
- Experience preparing written technical documents and presenting complex information
How to Apply: Please apply with your resume and covering letter, which must address the selection criteria above, and include the reference number R-203396 by June 16, 2023
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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.
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