Project Engineer - Site Tech Services (MDCP)

Our client, a leading pharmaceutical and medical device organization, is seeking a Project Engineer to provide technical, scientific, and project-driven support for manufacturing operations. The role focuses on leading technical improvements and sustaining on-market products through product change management and risk assessment activities.

• Lead project management activities including scoping, planning, and execution of technical improvement or investment projects.
• Support root cause investigations for delivery system customer complaints and implement appropriate corrective and preventive actions.
• Drive process and system improvements with a focus on enhancing and updating Design History Files.
• Prepare and execute design and process changes, including impact assessments and required requalification.
• Develop technical documentation such as protocols, reports, work instructions, and risk analyses.
• Coordinate with operations, quality assurance, and suppliers to ensure clear communication and on-time project delivery.

• You have a Master’s degree or higher in Mechanical, Biomedical, Chemical, or Manufacturing Engineering.
• You bring 3+ years of relevant experience in pharmaceutical or medical device manufacturing, technical support, or project engineering.
• You possess strong knowledge of GMP and technical standards within a regulated manufacturing environment.
• You have proven project management capabilities including planning, prioritization, risk control, and stakeholder engagement.
• You are analytical, detail-oriented, and able to collaborate effectively across different functions.
• You are fluent in English with knowledge of Dutch considered a plus.

Nice to Haves

• Strong knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971 regarding design controls and device risk management.
• Experience with injection molding technologies pertaining to the medical device or combination product industry.
• Direct experience with medical device or combination product technology.

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