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Operational Readiness Lead

3 weeks ago

Broadmeadows, Australia CSL Behring Full time

**The Opportunity**:
We are seeking a Process Specialist & Manufacturing Lead to join our Filling Value Stream in Broadmeadows. Reporting to the Senior Manufacturing Area Manager, you will provide manufacturing leadership and expertise for strategic projects and daily operations, collaborating with the Senior Manufacturing Manager on global and site projects related to yield and capacity. You will also focus on monitoring plant performance and implementing continuous improvements to enhance safety, quality, reliability, and innovation.

**The Role**:

- Plan and direct department production activities to meet the Master Production Schedule, monitor plant activities and establish and track KPIs.
- Build relationships with internal stakeholders and ensure compliance with GMP regulations through routine validation and maintenance programs.
- Deliver operational procedures and SOPs, ensure compliance with regulatory requirements, and support cross-functional teams to achieve on-time quality outcomes through effective communication.
- Ensure procedures and training modules are up to date and compliant with regulatory requirements and manage timely investigation and closeout of deviations and CAPAs.
- Ensure products and plant are compliant and validated, and that manufacturing adheres to registered conditions and GMP standards.

**Your skills and experience**:

- Tertiary qualification in science, engineering, business, or a related discipline.
- Minimum 7 years' experience within the pharmaceutical industry.
- Experience leading manufacturing and production operations and achieving operational targets.
- Technical skills in Manufacturing and Quality Process and Systems.
- Extensive knowledge of cGMP and quality systems.
- Experience within a pharmaceutical or allied industry involving line management.

LI - Onsite

**How to apply**

**Our Benefits**:
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

**About CSL Behring**:
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

**We want CSL 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.

**Do work that matters at CSL Behring**: