Validation Lead
Your Role
The Broadmeadows Site Validation Lead oversees the team accountable for planning and executing process and cleaning validations, ensuring compliance with company standards and governmental regulatory requirements.
Your role will include considering adequate risk-benefit aspects and investigating and troubleshooting validation problems. Situations faced are often technically complex and require extensive investigation and analysis.
Your Responsibilities
Reporting to the Senior Director, Process Engineering you will:
- Oversee validation support and staffing/resourcing for projects
- Define the validation strategy and the validation effort required for registrations (new license applications, extension of registrations, changes)
- Ensure that all manufacturing processes on site remain in a validated state, including cleaning processes
- Lead process risk assessments for the site manufacturing processes using defined risk management tools
- Develop staff competencies & capabilities within your team to enable sustained success and career development
- Oversee major projects and manufacturing support
- Oversee staff augmentation including contingent resources and external contractors
- Apply validation procedures to ensure compliance with global standards and regulatory guidelines
Your Experience
- Degree in Engineering or a relevant scientific discipline (Chemistry, Biology, Microbiology, etc.); advanced degree preferred but not essential
- Extensive experience in pharmaceutical manufacturing quality or operations management in a cGMP environment
- Direct Leadership/management experience in a validation or similar role
- Knowledge and experience with biologicals and aseptic processing
- Knowledge of current regulations and guidelines, industry standards and best practices for validation of biopharmaceutical products
- Knowledge of quality by design principles and tools
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!
Your Role
The Broadmeadows Site Validation Lead oversees the team accountable for planning and executing process and cleaning validations, ensuring compliance with company standards and governmental regulatory requirements.
Your role will include considering adequate risk-benefit aspects and investigating and troubleshooting validation problems. Situations faced are often technically complex and require extensive investigation and analysis.
Your Responsibilities
Reporting to the Senior Director, Process Engineering you will:
- Oversee validation support and staffing/resourcing for projects
- Define the validation strategy and the validation effort required for registrations (new license applications, extension of registrations, changes)
- Ensure that all manufacturing processes on site remain in a validated state, including cleaning processes
- Lead process risk assessments for the site manufacturing processes using defined risk management tools
- Develop staff competencies & capabilities within your team to enable sustained success and career development
- Oversee major projects and manufacturing support
- Oversee staff augmentation including contingent resources and external contractors
- Apply validation procedures to ensure compliance with global standards and regulatory guidelines
Your Experience
- Degree in Engineering or a relevant scientific discipline (Chemistry, Biology, Microbiology, etc.); advanced degree preferred but not essential
- Extensive experience in pharmaceutical manufacturing quality or operations management in a cGMP environment
- Direct Leadership/management experience in a validation or similar role
- Knowledge and experience with biologicals and aseptic processing
- Knowledge of current regulations and guidelines, industry standards and best practices for validation of biopharmaceutical products
- Knowledge of quality by design principles and tools
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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