Head of Process Validation
Description
Our client, a leading biotech company, is seeking a Head of Process Validation to lead validation activities for clinical and commercial cell therapy manufacturing in Belgium.
Responsibilities
* Oversee all process validation activities, ensuring compliance with GMP and regulatory requirements.
* Lead a team of process validation engineers, driving best practices in CAR-T manufacturing.
* Develop and implement validation strategies, author key validation documents, and support regulatory submissions.
* Serve as a validation SME for audits, process improvements, and investigations.
* Collaborate with internal and external stakeholders to align validation strategies globally.
Requirements
* Master's degree in Engineering, Science, or related field.
* 10+ years of experience in biologics tech transfer and process validation, ideally in cell/gene therapy.
* Strong leadership experience.
* Deep knowledge of GMP, biotherapeutics process validation, and regulatory requirements.
* Fluent in English; Dutch or French is a plus.