Validation Lead

1 week ago

Melbourne, Victoria, Australia Csl Behring Full time

**The Opportunity**:
Join the CSL Behring Validation team on a **full-time permanent basis**. CSL Behring Broadmeadows manufactures a comprehensive portfolio of 15 plasma products for Australia from plasma collected by the Lifeblood Australia. Part of the CSL family, when you join the over 1200 employees at Broadmeadows, you join an integrated global network of research and manufacturing facilities delivering on our 100-year-old promise to save lives using the latest technology.

As the **Validation Lead** you will manage the process and cleaning validation activities for across the CS: Behring Australia Business following the Site Validation Master Plan and validation procedures to deliver effective and compliant processes. As the Subject Matter expert, you will provide guidance to site staff for process and cleaning validation and work with across the site to ensure that validation activities are completed efficiently.

**The Role**:
Reporting to the Process and Analytical Lifecycle Management (PALM) Site Lead, and **working on site** at **Broadmeadows**, you will:

- Manage the continued process verification activities for the CSL Behring Australia;
- Manage the extractable and leachable activities for CSL Behring Australia.
- Ensure equipment and process control have been installed adequately to allow process and cleaning validation activities to be undertaken;
- Manage the development and maintenance of the process and cleaning validation master plans for CSL Behring Australia;
- Manage the departmental documentation for process and cleaning validation activities and prepare validation concepts;
- Conduct or participate in regulatory audits, investigations for validation deviations, change control panels and perform assessment of change controls for impact on validation status;
- Lead a small team and provide support to team to upskill and focused on continuous improvements.

**Skills and Experience**:
**To be considered for this role you **must** have**:

- A degree in science or engineering;
- 5+ years' experience in the pharmaceutical manufacturing industry in a cGMP environment with experience in Process and Cleaning Validation;
- Knowledge of cGMP including industry guidance documents and standards relating to validation;
- Experience leading a technical team in a regulated environment
- Experience in pharmaceutical industry regulatory requirements including TGA & FDA audits
- Experience preparing written technical documents and presenting complex information

**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**:

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