Job Summary
The Site Validation Director at CSL Behring will be responsible for leading a team that ensures the site's manufacturing processes remain in a validated state, including cleaning processes. This role requires considering adequate risk-benefit aspects and troubleshooting validation problems that are often technically complex.
Key Responsibilities:
* Oversee validation support and staffing/resourcing for projects.
* Define the validation strategy and effort required for registrations.
* Ensure manufacturing processes remain in a validated state, including cleaning processes.
* Lead process risk assessments using defined risk management tools.
* Develop staff competencies & capabilities within your team.
* Oversee major projects and manufacturing support.
* Apply validation procedures to ensure compliance with global standards and regulatory guidelines.
Requirements:
* Degree in Engineering or a relevant scientific discipline; advanced degree preferred.
* 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.