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Operational Readiness SME


Location: Parkville

Job Type: Full time


Job Description

The Opportunity

We have an exciting ongoing opportunity for an Operational Readiness SME to join our dynamic team at Seqirus, on Banksia project. Reporting to the PNS Lead – Project Banksia and based at our Tullamarine site, you will provide subject matter expertise to support the Project Banksia Operations team during the project and commercial operations. This role will actively participate in the Banksia project team collaborating closely with project leaders and teams to support operations requirements across design, commissioning, qualification and validation. You will also oversee the licensure of the facilities and registration of manufacturing processes for commercial operation.

The Role

  • Provide operational knowledge and support during commissioning and qualification of new equipment, automation and software for the project
  • Prepare and review Operations SOPs, Risk Assessments, Batch Documents MES input and all other documents as required for C/Q/V project stages for equipment, facility, technical transfer and manufacturing processes
  • Ensure the process for the engineering and validation batches are delivered in accordance with the project schedule and product schedule
  • Encourage use of risk-based continuous improvement and operational excellence methods across the project to drive improvements in compliance, throughput, efficiency and robust operations
  • Build and maintain strong professional and collaborative relationships with internal/external stakeholders to meet all operations deliverables
  • Provide employee education opportunities including training initiatives that develop our people while enhancing their skills and knowledge, driving engagement and the key behaviours that align with our business strategy

Your skills and experience

  • Tertiary qualification in Engineering, Science or related degree
  • 5 years' experience in a production area in the pharmaceutical industry
  • Functional knowledge of cGMP and manufacturing operations in FDA/TGA regulated facility
  • Regulatory awareness, capable of contributing to Regulatory inspection
  • Involvement in delivering capital projects, knowledge of Validation, CMC and facility regulatory submission requirements
  • Strong leadership skills, ability to influence, and drive cross business collaboration

How to apply

Please send us your resume and covering letter (in one document), which addresses the criteria above and includes reference number R-184565.

Applications close 2nd December 2022.

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.

About 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.

We want Seqirus to reflect the world around us

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

Do work that matters at Seqirus!