Process Engineer I – Manufacturing Operations & Compliance Support

Location: Hoofddorp, NL

Salary: €51,760 - €58,230/year

Department Overview

For our client in the biopharmaceutical industry, we are looking for a motivated Process Engineer I with a strong sense of compliance and a passion for continuous improvement. You will join the Manufacturing Operations and Compliance Support (MOCS) team within the MSAT department at the commercial manufacturing site in Hoofddorp, where they produce cutting-edge T-cell therapies.

About the Role

As a Process Engineer, you will play a key role in driving quality and operational excellence. Your responsibilities will include conducting root cause investigations and leading continuous improvement initiatives (e.g., CAPAs) to support the manufacturing operations.

Your Key Responsibilities:

• Collaborate with technical and operational teams to write and revise SOPs, batch records, and other operational documents
• Investigate deviations using structured Root Cause Analysis tools and coordinate resolution activities
• Develop and implement Corrective and Preventive Actions (CAPAs) to address root causes and ensure long-term effectiveness
• Support other duties as assigned by Management

What We’re Looking For:

• Experience in cell culture, cell therapy, or aseptic processing
• Solid understanding of cGMP compliance and hands-on experience with deviations, investigations, change controls, and CAPAs
• Strong communication skills and ability to work effectively in cross-functional teams
• Good grasp of scientific and engineering principles
• Adaptable and comfortable working in a fast-paced, dynamic environment
• Self-motivated, detail-oriented, and able to take on new responsibilities as needed
• Excellent problem-solving and troubleshooting skills

Education & Experience Requirements:

• BSc in Biochemical Engineering, Chemical Engineering, Biotechnology, or related field (Engineering degree is a strong plus)
• 2–3 years of experience as a Process Engineer in a GMP-regulated pharmaceutical manufacturing environment
• Deep knowledge of manufacturing processes and strong technical writing abilities
• Excellent interpersonal skills

Are you interested?

Send your latest CV via "Easy Apply", or contact:

Audrey Poluakan - Recruitment Consultant at Grafton Recruitment

[email protected]