Process Development Engineer
$8,320,000–$10,400,000 year
On-siteBilthoven, Provincie Utrecht, Kingdom of the Netherlands
Job Summary
Serve as the primary engineering contact for daily manufacturing issues, investigating and resolving equipment, process, and product-related deviations to minimize downtime. Provide real-time support to production personnel while performing root cause investigations using structured methodologies like 5-Why or DMAIC. Lead and document troubleshooting activities for manufacturing events and non-conformances, supporting disposition activities and technical assessments. Collaborate with Production, Quality, Validation, Maintenance, Supply Chain, and R&D teams to implement corrective actions and drive continuous process improvements in a GMP-regulated environment.
Required Qualifications
- HBO (BSc) / University (MSc.) in the field of Biomedical Engineering / Medical Biology
- 5+ years of experience in process development or manufacturing engineering, preferably in the medical device or pharmaceutical industry
- Experience with IQ/OQ/PQ protocols and process validation
- Good knowledge of English language required
- Excellent communication skills to collaborate with cross-functional team, internal and external parties, present findings and document processes
- Strong Analytical skills and problem-solving skills
- Effective project planning, execution and tracking to meet deadlines and budgets
- Continuous improvement experience and project management skills. Ability to design and improve manufacturing processes
- The ability to think creatively and come up with innovative solutions
- Collaborating effectively with colleagues including operators, technicians and other engineers
- Comfortable working in a fast-paced, regulated environment
Desired Qualifications
- Previous experience with working in a GMP environment and/or ISO 13485 is preferred
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.