Job Description

The Opportunity

Derived from the expression 'securing health for all of us', CSL Seqirus is a global leader in influenza protection. In Asia Pacific we also manufacture and distribute a range of uniquely Australian products market a range of in-licensed vaccines and pharmaceuticals in Australia and New Zealand.

We are looking for a Senior Validation Specialist to join the Analytical Sciences and Technology (AS&T) team on a full-time basis. This role is fixed term until 30/6/2025. For current permanent employees the position may be offered as an ongoing role. Located in Parkville (Australia), you will perform Quality Control (QC) method validation, lifecycle management and method standardisation and robustness. You will also be the subject matter expert (SME) for EIAs and the SRID assay.

The Role

Reporting to the Senior Manager of AS&T, you will:

• Maintain the compliant status of the QC method validation lifecycle;

• Lead investigations into technical challenges with QC test methods to find solutions;

• Develop of current and new test methods and maintain knowledge of improvements in testing technologies;

• Review data generated from validation activities and highlight any detrimental trends or deviations identified;

• Coordinate intra-site method transfers;

• Provide technical input into regulatory filings/audits;

• Perform Testing of Critical Process Parameter Activities and help maintain the facility.

Your skills and experience

To be considered for this role, you have:

• Tertiary qualification in Biological Sciences, ideally biochemistry or chemistry;

• Minimum 5 years' experience in a relevant pharmaceutical laboratory environment;

• Experience of Quality Control testing techniques and industry practices

• Knowledge of cGMP regulations and Quality Management Systems;

• Experience in a role requiring the resolution of complex problems and collaboration with different teams;

• Experience communicating complex information both verbally and in writing.

How to apply

Please send us your resume and covering letter (in one document), which addresses the criteria above and includes reference number R-214497 by October 7, 2023.

About Us

Our Benefits

Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.