AS&T Validation Specialist

Reporting to the Head of Analytical Science and Technology at Seqirus Liverpool the role is accountable for Quality Control method

validation lifecycle management and method standardisation/robustness. The validation specialist is an SME in testing

methodology, able to troubleshoot technical issues, develop current and existing methods and be current with the latest analytical

testing technologies. The role requires the execution of intra site method transfers and SME input into regulatory filings/audits

alongside validation lifecycle management.

Routine testing support for technical development / MS+T pilot plant manufacturing processes required in support of critical

manufacturing process parameter activities and new strain introduction. (as required)

Responsibilities

1. Maintain the compliant status of QC method validation lifecycle. 40%

2. Trouble shoot technical challenges with QC test methods. 15%

3. Execution of method standardisation and robustness program 15%

4. Development of current and new test methods. Engaged with the latest testing technologies 10%

5. Execution of intra site method transfers and SME input into regulatory filings/audits 10%

6. Support Testing of Critical Process Parameter Activities and maintain facility including;

• • Instrument Maintenance and Calibration
• • Reporting of Results.
• • Reagent and Standard Qualification
• • HSE risk assessment completion, review and adherence
• • Archiving of laboratory documentation,
• • Ordering of reagents and consumables
• • Maintenance of AS+T sample and reagent stores
• • Ensuring a clean and safe workplace for all associates •
• Participation in quality risk assessments

Experience Requirements

• Experience working in pharmaceuticals, particularly biologics
• Experience of assay development and assay validation
• Experience in elements of assay lifecycle management from proof of concept to registration.
• Experience of Quality Control testing techniques and industry practices.
• Proven time management skills for planning and schedule of work.
• Proven Communication skills both written and verbal.
• Knowledge of continuous improvement techniques and root cause analysis techniques.
• Bachelor's degree in a relevant scientific discipline (Chemistry, Biochemistry, Microbiology preferred)
• Desirable to have experience of process or product characterization using a variety of orthogonal methods.

Our Benefits

CSL 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 CSL Seqirus.

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

We want Seqirus 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 Seqirus.

Do work that matters at CSL Seqirus!

Watch our 'On the Front Line' video to learn more about CSL Seqirus