Quality & Manufacturing Support Engineer, Hoofddorp, Noord-Holland

The Company 
Our client is  a biotechnology company focused on developing innovative cancer therapies, particularly in the field of immuno-oncology. They specialize in harnessing the body’s immune system to target and destroy cancer cells, with a particular emphasis on engineered T cell therapies. 

The Role
You are responsible for supporting manufacturing operations and ensuring compliance at a pharmaceutical/biotech facility. In this role, you will conduct root-cause investigations, implement corrective and preventive actions (CAPAs), and manage deviations to improve processes for T-cell therapy production. You will collaborate with cross-functional teams, write and revise operational documents, and ensure adherence to cGMP standards.

Responsibilities

• Conduct thorough investigations into process deviations and identify their root causes using appropriate tools
• Develop and implement CAPAs to address root causes and ensure the effectiveness of solutions.
• Manage and resolve deviations in manufacturing processes to maintain compliance with cGMP standards.
• Write, review, and update SOPs, batch records, and other operational documents in collaboration with technical and operational teams.
• Lead continuous improvement initiatives to enhance manufacturing efficiency and product quality.
• Ensure all manufacturing operations align with cGMP regulations and other relevant compliance standards.
• Work closely with various departments (quality assurance, engineering, manufacturing) to support smooth production and resolve technical challenges.

• Background in cell culture, cell therapy, or aseptic processing with knowledge of cGMP compliance and handling investigations and corrective actions. Knowledge of GVAULT is preferred. 
• Bachelor’s in Biochemical Engineering, Chemical Engineering, Biotechnology, or related field.
• Strong troubleshooting and analytical skills with a solid grasp of scientific and engineering principles.
• Excellent verbal and written communication skills, with experience in cross-functional collaboration.
• Self-motivated, detail-oriented, and able to work independently in a dynamic, fast-paced environment.

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