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.