Senior Validation Advisor - R&D

The Opportunity
CSL is looking for a Senior Validation Advisor to join the Product Development & Research Quality team at our Melbourne office.
Reporting to the R&D Validation Manager - Australia, you will be responsible for the coordination and execution of phase appropriate qualification and validation activities for CSL’s R&D business’ Australian sites at CSL Melbourne, Bio21 and Broadmeadows.
The Role

• Plan, perform (or oversee) and coordinate phase-appropriate qualification and validation activities associated with new, or changes to existing, processes, equipment, facilities and utilities as required at CSL R&D.
  
• Provide technical specialist advice on qualification and validation issues / concepts to R&D functions.
  
• Perform re-validation activities and validation reviews as scheduled.
  
• Participate in internal (e.g., Quality Compliance, Safety and departmental) and external (e.g., TGA, NATA) audits, as requested.
  
• Assist in the preparation, review, implementation, and maintenance of R&D documentation for qualification and validation activities.
  
• Provide subject matter expert guidance and mentoring to site staff in validation and the associated regulatory requirements.
  

Your skills and experience

• A relevant science or engineering tertiary qualification (e.g., Biological Sciences, Chemical Engineering, Pharmacology, Pharmaceutical Sciences etc.)
  
• 4+ years of experience in pharmaceutical industry with experience in manufacturing and laboratory equipment, facilities & utilities qualification and validation
  
• Strong knowledge of cGxP including current knowledge of industry guidance documents and standards focusing on qualification and validation principles and applications
  
• Excellent verbal and written communication skills
  
• Strong time management skills, with the flexibility to manage changing priorities and multiple tasks
  
• Stakeholder relationship and management
  

How to apply
Please submit your application including CV and cover letter by 31 January 2024.
Apply now to join a world-class pharmaceutical organisation that is continuing to grow and be part of 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
CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL.
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!