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Manager, Quality Engineering Method Transfer & Stability

CSL Australia - Broadmeadows, VIC

Source: uWorkin


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!

  • ASX Top 5 | Leading Bio-pharmaceutical Company | Life-Saving Therapies
  • Full Time, Permanent Position, based in Broadmeadows
  • Work in a diverse and versatile role | Global Employee Share Plan

The Opportunity

Reporting into the Quality Engineering Methods Transfer & Validation Leader, the Methods Transfer & Validation Manager will be provide oversight for projects covering methods transfer & validation. You will partner with the process and product owners of Capex projects at the Broadmeadows manufacturing site. In addition, you will support QA oversight of quality standards and systems aligned with the Engineering functions in methods transfer, validation and cGMP compliance.

The Role
  • Collaborate with internal partners for the execution of all capital projects - EU, AUS and US and others - to deliver projects on time and to the required standards and regulatory requirements
  • Delivers a consistent quality approach to facility and process design and development for capital projects
  • Provide QA oversight on process within capital project
  • Support regulatory document submissions and pre-approval inspections for capital projects
  • Collaborate with peers in Engineering across manufacturing sites with internal partners for the execution of all methods transfers and method validation to deliver these changes on time and to the required standards
  • Carries out Quality decisions regarding methods transfer, method validation and comparability studies are aligned with the direction of the organisation
  • Participate in risks assessments and ensures up-to-date information
  • Ensures quality is represented appropriately for regulatory document submissions and regulatory inspections for technical transfer and the corresponding activities
  • Delivers to global engineering standards and processes consistent with regulatory requirements and industry standards (quality systems, policies, procedures and work instructions)
  • Provides input to engineering on the content of an appropriate Documentation and Knowledge Management system for the Engineering function
  • Delivers against global standards for technology transfer and , validation
  • Participate in deviations, SQUIPP assessment, ensure compliance of the final deviation reports

Skills and Experience
  • University degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
  • 5+ years' GMP experience in pharmaceutical/biotech/or other regulated industry
  • Experience within a global matrix organisation
  • Knowledge of current Good Manufacturing Practices (cGMP) principles
  • Knowledge of appropriate regulatory requirements and experience in associated regulatory inspections
  • Exceptional communication skills, with the ability to build and maintain strong relationships and collaborate 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 in your application a Cover Letter and CV. Applications close 5pm AEST on Thursday 17 June 2021.

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 becoming 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.

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