Validation Specialist

2 months ago

Parkville, Australia Seqirus Full time

**The Opportunity**:
Located in Parkville (Australia) and part of the Analytical Sciences and Technology (AS&T) Department a **12 month fixed term contract** opportunity has become available for a **Validation** **Specialist** to participate in the validation and implementation of scientific methods and technologies into the Quality Control laboratories.

**The Role**:
Specifically, the Validation Specialist will:

- Demonstrate supervision and support for timely implementation of projects and ensuring training requirements are met.
- 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 attending team meetings, creating required documentation, and conducting assessment testing.
- Contribute to Assay Development Teams to ensure 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**:

- A Bachelor of Science or equivalent
- Previous laboratory testing experience
- Demonstrated experience in biochemistry and/or chemistry techniques will be highly regarded
- Previous experience in a quality environment
- Good technical and mechanical aptitude
- Excellent Microsoft Office Skills

**In addition, you have**:

- Previous experience working in the Pharmaceutical industry
- Sound 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**

**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.

**We want CSL 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

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