Vacancy: Process Engineer (Cell Therapy / MSAT)

📍 Hoofddorp, Netherlands | 🕒 Full-time | 📅 12-month contract (extension possible)

About the Role

We are looking for a motivated Process Engineer to join a dynamic and fast-growing biopharmaceutical organization specializing in cell therapy manufacturing.

In this role, you will support manufacturing operations by ensuring compliance, driving process improvements, and resolving technical issues. You will work closely with cross-functional teams to maintain high-quality standards within a cGMP-regulated environment.

Key Responsibilities

• Perform impact assessments to support product release
• Lead and execute root cause investigations and deviation management
• Author and manage deviation reports, change controls, and CAPAs
• Develop, review, and update SOPs and batch documentation
• Collaborate with cross-functional teams (Manufacturing, QA, QC)
• Identify and implement continuous improvement initiatives
• Provide technical support for manufacturing processes

Your Profile

Education

• Bachelor's degree (BSc) in Biochemical Engineering, Chemical Engineering, Biotechnology, or a related field
• An Engineering degree is considered a strong plus

Required Experience

• Hands-on experience in:
  • Cell culture, cell therapy, and/or aseptic processing
• Strong knowledge of:
  • cGMP regulations
  • Deviation handling, investigations, and change control processes
• Proven experience with:
  • CAPA management and technical documentation

Skills & Competencies

• Excellent communication and collaboration skills
• Strong analytical thinking and problem-solving abilities
• Able to work independently and in a fast-paced environment
• Flexible and adaptable to changing priorities
• Detail-oriented, self-motivated, and proactive
• Willing to take on responsibilities beyond initial scope

What We Offer

• 12-month contract with potential extension based on business needs
• Opportunity to work in a cutting-edge biotech environment
• Exposure to innovative cell therapy manufacturing processes
• Collaborative and high-performing team culture