Project Engineer Site Technical Services (MDCP)

Our client, a leading pharmaceutical organization, is seeking a technical expert to provide project-driven support for robust manufacturing operations. This role focuses on sustaining on-market medical devices and combination products through technical improvements, process changes, and risk management activities. The position acts as a bridge between production and R&D to facilitate product launches and ensure continuous improvement.

• Lead and support technical improvement and investment projects from scoping and planning to execution.
• Investigate delivery system customer complaints to determine root causes and implement effective CAPA.
• Drive process and system enhancements with a focus on Design History File (DHF) updates and risk management.
• Prepare and execute technical documentation including protocols, reports, and impact assessments for design and process changes.
• Coordinate with cross-functional teams and external suppliers to ensure on-time delivery and clear communication.
• Support quality assurance in the disposition of non-conforming reports and the qualification of materials or processes.
• Identify and communicate technical risks while developing appropriate mitigation strategies for stakeholders.

• You have a Master’s degree in Mechanical, Biomedical, Chemical, or Manufacturing Engineering.
• You have 3+ years of experience in project engineering or technical support within the pharmaceutical or medical device sector.
• You bring expertise in quality and technical standards including GMP, CAPA, and root cause analysis.
• You possess project management capabilities covering planning, prioritization, and stakeholder engagement.
• You are proactive, detail-oriented, and possess strong analytical problem-solving skills.
• You are fluent in English with knowledge of Dutch considered a plus.

Nice to Haves

• Knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971 standards.
• Experience with injection molding technologies pertaining to the medical device industry.
• Direct experience with Medical Device and Combination Product (MDCP) technology.

• Bénéficiez d'un package salarial compétitif avec des avantages supplémentaires qui récompensent votre talent.
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