With operations in 35+ nations and ~ 27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

• Australia's largest pharma manufacturing site undergoing significant growth
  
• Oversee sterility assurance global validation control governance across all CSL Behring sites globally
  
• New Full Time, Permanent Position | Flexible Working | Global Employee Share Plan
  

The Opportunity
Reporting into the Global Director Sterility Assurance, the Global Lead Sterility Assurance - Validation Controls will be responsible for the Quality oversight for the contamination control validation elements including facility qualification, utility and equipment qualification, process qualification and method qualification.

You will be accountable for all sterility assurance global validation control governance and life cycle management at all CSL Behring sites. In this newly created role, you will be pragmatic, a self-starter and adaptable during this time of growth. This position is based in Melbourne Australia, however can be based from other locations across the globe. In the future, global travel will be a requirement of this position.

The Role

• Collaborate with internal partners for the design of best practice validation controls for the microbial contamination control strategy and life cycle management
  
• Deliver on time and to the required standards and regulatory requirements with respect to validation activities affecting sterile manufacturing (Fill / Finish area including filling, lyophilizers, sterilizers, isolator technology and auxiliary equipment)
  
• Ensure appropriate development, implementation and maintenance of global validation control standards and processes consistent with regulatory requirements and industry standards (quality systems, policies, procedures and work instructions)
  
• Responsible for Quality decisions for capital projects in area of consultation with global Sterility Assurance and local Quality Assurance Operations leaders
  
• Support to local and global capacity expansion projects to ensure reliable supply for our patients
  
• Review and evaluate the validation of new methods and new technology to improve the microbial contamination controls
  
• Provide leadership and expertise to the local Sterility Assurance quality team
  
• Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve
  
• Develop and ensure that global standards are met for best practice and validation
  
• Support continuous improvement and innovation initiatives relating to aseptic and sterile processing
  

Skills and Experience

• Undergraduate degree in Microbiology/life sciences, coupled with +10 years of demonstrated experience within the aseptic pharmaceutical industry
  
• Extensive professional experience in leading teams with respect to aseptic cleanrooms, process, equipment, consumables and utilities
  
• Direct experience executing Quality Assurance function and system within a manufacturing and QC Microbiology/Sterility Assurance context
  
• Demonstrated experience in quality assurance and regulatory compliance with GxP, FDA, EU and other regulatory agency guidelines
  
• Experience in working in a global environment
  
• In depth knowledge and experience of performing risk-based assessments and root cause investigations
  
• Ability to build and maintain strong relationships whilst communicating and collaborating effectively with all levels and cross functionally within the organisation
  

How to apply

Apply now to support CSL Behring during next phase of growth. Please include a Cover Letter and a CV in your application.

As a global organisation with employees in more than 30 countries, CSL embraces diversity & inclusion. It's the foundation of who we are. Diversity and inclusion are critical to our Values of patient focus, superior performance, innovation, integrity and collaboration. As a company, we rely on our people's diverse perspectives, ideas, capabilities and experiences to help us deliver on our promise to our patients, our business and our shareholders.

Our Culture
At CSL, we are driven by our promise to stakeholders, including our employees. CSL is committed to building a workplace where employees can have Promising FUTURES by fulfilling their career aspirations, realising their potential and being part of a purpose-driven company with a Values-based culture.

Whether you are an expert in your field,moving across, or upward in the organisation, we believe our people can enjoy Promising FUTURES where they fulfil their individual career aspirations and are inspired by our purpose-driven company and values-based culture. Our environment is collaborative, global and dynamic, which fosters innovation and motivates the best and brightest to succeed.

Worker Type:
Employee

Worker Sub Type:
Regular