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Head of process validation


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.

Solliciteren