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.

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