The Opportunity
CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza.
We're currently looking for a MS&T Process Engineer to join the Global MS&T Technical Solutions - Seqirus group at our Tullamarine site.
Reporting to the MS&T Lead Process Engineer, you will be accountable to fulfil the delivery of Project Banksia Technology Transfer for Antivenom, Q-Fever Vaccine, FCC Drug Substance and Drug Product manufacture at the Tullamarine (Melbourne, Australia) and Woodend (Victoria) facilities.
This is a 12-month fixed term role with possibility to extend for the right candidate. For current CSL employees, the role will be a fixed term or secondment role depending on your current employment status.
The Role:
As a Process Engineer, you will:
1. Provide support to the technology transfer team as the primary point of contact for technical and operational equipment/process issues. Define, scope, evaluate, execute and when needed troubleshoot and investigate equipment/product problems in the bulk sterile liquid process manufacturing facility.
2. Help develop manufacturing documentation including procedures, batch records, training materials and specifications.
3. Maintain knowledge on the relationship between the process, the equipment, and the automation in the facility. Ensure that equipment works to its specification and capacity.
4. Ensure on-time implementation of processes, continuous improvement in quality, yield and efficiency; performed in compliance to cGMP's, SOPs, and applicable guidelines.
5. Provide leadership and ownership of all assigned actions/deliverables within assigned projects.
6. Interact with both internal and external stakeholders and will serve as the "face" of Seqirus during technical transfers. Collaborate with multiple internal functions like manufacturing, QA, engineering, QC, metrology, etc. to complete project deliverables, approve documentation, troubleshoot processing issues.
Your skills and experience
7. Degree in Engineering or Science.
8. 5+ years of experience in engineering, quality, validation and/or operations in the pharmaceutical industry, or related areas in a manufacturing environment.
9. Preference for direct experience with regulatory requirements, clean room environments or GMP environment.
10. An understanding of end-to-end manufacturing, engineering, equipment, and automation principles and able to apply this knowledge.
11. Mechanical aptitude and knowledge of mechanical equipment.
How to Apply
Please submit your application including your CV and Cover Letter addressing the selection criteria listed under Your Skills & Experience section above.
Applications close on 02 July 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.