Validation Specialist

The Opportunity
We are looking for a Validation Specialist to join the Analytical Sciences and Technology (AS&T) team in Parkville Australia. In this interesting, fixed term role, until 30 June 2025, you will participate in the validation and implementation of scientific methods and technologies into the Quality Control laboratories.
The Role
Reporting to the Senior Manager Site Analytical Services & Technology and working on site, you will:

• Support the implementation of projects and ensuring training requirements.
• Participate in routine internal audits, ensuring all audit items are closed out as per agreed timeline.
• Participate and perform in document write up and review for Regulatory submissions.
• Collaborate with QC, Production, QA, Document Control, and all R&D groups to implement selected technologies into the QC laboratories.
• Collaborate with external colleagues and companies to maintain knowledge of current assay developments and current scientific technology.
• Participate in Assay Development Teams including creating required documentation, conducting assessment testing and ensuring milestones are met for development and transfer with efficient use of labour and material resources.
• Create required documentation as outlined in relevant procedure for testing and standard operating procedures for implementing new methods and technologies.
• Conduct analyst training within AS&T and QC Laboratories for transferred technologies.
• Maintain associated databases of relevant information to AS&T and support project monitoring systems.

Your skills and experience
To be considered for this role you have:

• A Bachelor of Science or equivalent
• Previous laboratory testing experience with experience in biochemistry and/or chemistry techniques
• Experience in the pharmaceutical industry
• Good technical and mechanical aptitude
• Understanding of the process for the development and validation of analytical test methods.
• Understanding of the ICH/EMEA guidelines and Pharmaceutical Regulatory Requirements
• Previous experience in project management

How to apply
Please send us your resume and covering letter (in one document), which addresses the criteria above and includes the reference number R-227908 by 7 April, 2024.
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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. In Australia, CSL Seqirus is also a leading provider of speciality pharmaceuticals and other essential vaccines. Learn more about CSL Seqirus.
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