Manufacturing Process Engineer for GMP & CI

Kuros Biosciences; Bilthoven; On-site; EUR 60,000 - 85,000; Full time

Job summary

Kuros Biosciences in Bilthoven, Netherlands, is seeking a Manufacturing Process Engineer to support day-to-day manufacturing operations, equipment, and facility systems to ensure GMP-compliant production of orthobiologics. The role collaborates with QA, Engineering, and Facilities to maintain compliance, resolve deviations, and drive operational excellence.

You will analyze data, develop KPIs, support CAPAs and investigations, and continuously improve processes while coaching senior operators

Qualifications

• Bachelor’s degree in engineering, technical operations, manufacturing technology, or related discipline.
• Minimum 2 years of experience in a regulated manufacturing environment; medical device, pharmaceutical, or biotechnology experience preferred.
• Experience with quality management systems, including deviations, non-conformities, CAPAs, and change control processes.
• Experience with supporting manufacturing equipment, facilities, maintenance, or calibration programs.
• Basic knowledge of GMP, quality systems, lean manufacturing, continuous improvement, or risk-based problem-solving methodologies is a plus.
• Strong written and verbal communication skills in English.

Responsibilities

• Provide hands-on technical support and troubleshooting to manufacturing operations to ensure safe, compliant, and efficient production processes.
• Investigate manufacturing deviations, process abnormalities, and non-conformities; perform root cause analyses and support CAPAs.
• Support execution and effectiveness of change controls related to processes, equipment, and procedures.
• Follow up on audit observations and support compliance-related improvement actions.
• Analyze manufacturing data and develop KPIs to identify trends and opportunities for process improvement.
• Drive continuous improvement initiatives through Lean methodologies to enhance quality and efficiency.

Skills

Hands-on mindset

Manufacturing operations

Analytical skills

Troubleshooting

Stakeholder management

Education

Bachelor’s degree in engineering

Tools

Quality Management Systems

Job description

Kuros Biosciences in Bilthoven, Netherlands, is seeking a Manufacturing Process Engineer to support day-to-day manufacturing operations, equipment, and facility systems to ensure GMP-compliant production of orthobiologics. The role collaborates with QA, Engineering, and Facilities to maintain compliance, resolve deviations, and drive operational excellence.

You will analyze data, develop KPIs, support CAPAs and investigations, and continuously improve processes while coaching senior operators