Quality Systems Engineer, Leiden, Zuid-Holland

The Company
Our client is a leading biopharmaceutical company based in Leiden, focused on developing and manufacturing innovative biologic medicines. They specialize in delivering high-quality therapies and driving advancements that improve global health and patient outcomes.

Role Description
As a Quality Systems Engineer, you will play a key role in ensuring that all engineering, maintenance, and qualification activities meet GMP and internal quality standards. You will lead initiatives to improve internal processes, support validation efforts, and promote a culture of continuous improvement within the EVM department.

Responsibilities

• Act as subject matter expert on validation and qualification activities.
• Lead and support continuous improvement initiatives across the department.
• Provide guidance on GMP compliance in maintenance and engineering processes.
• Support and coordinate CAPAs, deviations, and internal audits.
• Develop and maintain performance metrics and visual management systems.

Requirements

• Bachelor’s degree in Mechanical, Electrical, Process Engineering or similar.
• 4–8 years of experience in a similar role within a GMP-regulated environment.
• Strong knowledge of GMP, validation, and regulatory guidelines (e.g. FDA, ICH, ISPE).
• Certified in Process Excellence methodologies (Green Belt preferred).

Other Information
Apply to our vacancy for more information. looking forward to hearing from you.

56379