Manufacturing Process Engineer in Bilthoven, Nederland

Kuros Biosciences is a Swiss-listed life science company with offices in Bilthoven (The Netherlands), Atlanta (USA) and Schlieren (Switzerland). Kuros focuses on the development and marketing of orthobiologics for spinal fusion surgery, a procedure used to stabilize the spine in patients with back problems. The Kuros bone repair products are developed and manufactured in Bilthoven and sold worldwide. The Kuros Bilthoven Production Team is looking for a Manufacturing Process Engineer, a new team member that fits the spirit of an innovative company and entrepreneurial aiming to become the global leader in orthobiologics. This position will report to the Bilthoven office.

Position Overview

The manufacturing support engineer supports the day-to-day operation of manufacturing processes, production equipment, and facility systems to ensure the safe, compliant, and efficient manufacture of Kuros products. The role provides technical support to production and assists quality engineering and quality control in identifying and resolving deviations and non-conformities. Working closely with quality assurance and quality engineering, the manufacturing support engineer also supports the resolution of corrective and preventive actions (CAPAs), as well as the maintenance, calibration, and continuous improvement of manufacturing equipment and facilities. As part of the production department, the role collaborates with process development engineering, quality assurance, quality engineering, and facilities to maintain compliance with GMP and regulatory requirements and to drive operational excellence.

Position tasks and responsibilities

• Provide hands-on technical support and troubleshooting assistance 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 the implementation of corrective and preventive actions (CAPAs).

• Support the execution and effectiveness of change controls related to manufacturing processes, equipment, and procedures.

• Follow up on internal and external audit observations and support compliance-related improvement actions.

• Analyze manufacturing data and develop KPI's to identify trends, risks, and opportunities for process improvement.

• Support risk assessments, problem-solving activities, and data-driven decision making within production.

• Drive and support continuous improvement initiatives through the application of Lean methodologies to improve quality, efficiency, and process robustness.

• Coach and support senior operators in troubleshooting, process understanding, problem-solving, and continuous improvement activities.

• Maintain accurate and compliant work instructions, manufacturing documentation, and quality records.

• Support GMP compliance by ensuring manufacturing activities are performed in accordance with company procedures, quality standards, and regulatory requirements.

• Support investigations related to customer complaints, product quality issues, manufacturing events, and audit findings.

• Assist with equipment installation, commissioning, qualification, validation, and new product implementation activities.

• Support maintenance and facility-related activities, including preventive maintenance, calibration planning, equipment reliability improvements, and coordination of external service providers.

• Collaborate with Production, Quality, Engineering, Maintenance, and Facilities to resolve operational challenges and implement sustainable improvements.

• Promote a culture of quality, safety, accountability, and continuous improvement throughout the organization.

• Perform additional duties and responsibilities assigned to support business, manufacturing, quality, maintenance, or facility objectives.

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 considered a plus.

• Strong written and verbal communication skills in English.

Skills

• Hands-on and practical mindset with a strong interest in manufacturing operations.

• Strong analytical, troubleshooting, and problem-solving skills.

• Curious, eager to learn, and continuously looking for opportunities to improve.

• Structured and organized way of working with strong attention to detail.

• Proactive, self-driven, and capable of working independently.

• Strong communication and stakeholder management skills with the ability to collaborate across functions.

• Ability to translate data, observations, and operational challenges into practical improvements.

• Strong sense of ownership, accountability, and follow-through.

• Flexibility, perseverance, and resilience in a dynamic manufacturing environment.

• Affinity with Continuous Improvement, Lean Manufacturing, GMP, root cause analysis, data analysis, deviations, CAPAs, change controls, maintenance support, and manufacturing processes.

• The role requires a strong presence on the shop floor to understand operational challenges, support problem solving, and identify opportunities for continuous improvement.

Why Kuros Biosciences?

Join an international, innovative company with a diverse and energetic team. At Kuros, you'll work in a positive and collaborative environment, contributing to the development of life-changing products. We offer great benefits, a competitive salary, and opportunities for career growth.