Validation Scientist

Location:, Broadmeadows
Job Type:Full Time

About CSL

With operations in 35+ nations and ~ 22,000 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!

Job Description

The Opportunity

An exciting opportunity has become available for a Validation Scientist in the Quality function at CSL Behring. This position is responsible for planning, developing and executing process and cleaning

validation activities associated with modifications and changes to processes and projects, as allocated, for the CSL Behring Australia business ensuring activities are implemented to industry and regulatory standards.

The Role

Reporting to the Team Leader Process and Cleaning Validation, your responsibilities will include:

  • Build and maintain strong collaborative relationships with key stakeholders to ensure validation activities are planned and delivered in an efficient timeframe
  • Perform validation activities associated with changes to existing processes/materials, new processes/materials and projects as required at CSL Behring Broadmeadows to deliver successful validation outcomes
  • Planning and execution of validation activities in operations
  • Evaluation and review of validation data
  • Prepare, implement and maintain departmental documentation for validation activities and regulatory submissions (e.g. validation protocols and reports, executive summaries and validation master files) ensuring these meet CSL procedures and regulatory requirements
  • Perform validation activities in accordance with the Quality Management System, Site Validation Master Plan and Validation procedures to meet the requirements of all codes, regulations and CSL policies

To be successful:

  • A relevant science or engineering tertiary qualification
  • Computer literacy and experience using Microsoft applications and statistical analysis software.
  • Sound knowledge of cGMP
  • Strong customer focused
  • Good verbal and communication skills
  • Sound knowledge of industry guidance documents and standards, with a good
  • understanding of validation principles
  • Good verbal and written communication skills and strong problem solving skills

Applications close 5pm AEST on the 6th March 2020.

Applications must address the selection criteria above and include a current CV and covering letter.

Apply now for a role with a varied remit in an organisation that is going through considerable investment and change.

Employment screening, including criminal history, medical assessment, confirmation of experience and stated qualifications, Australian working rights and other relevant checks form part of the candidate suitability evaluation process.