NPI Engineer

Overview

Leading transfer projects from development to manufacturing, starting from the engineering design phase through to commercial production, in a highly regulated environment. The role includes responsibility for managing engineering projects, performing process validations, and coordinating with various internal and external interfaces.

Responsibilities

• Leading NPI (New Product Introduction) projects from product design through to full implementation on production lines
• Managing development-to-manufacturing transfer processes, including work plan preparation, risk analysis, engineering definitions, and product documentation
• Responsible for process validations (IQ/OQ/PQ) in accordance with regulatory requirements in the pharma/medical field
• Ongoing coordination with R&D, Operations, Quality, Regulatory Affairs, Procurement, Manufacturing, and other departments
• Identifying engineering bottlenecks and providing solutions to improve performance, quality, and process efficiency
• Leading engineering processes in compliance with standards and procedures (ISO 13485, GMP, FDA)
• Maintaining complete engineering documentation and ensuring continuous knowledge transfer to the production floor
  
  

• B.Sc. in Engineering – Mechanical, Biomedical, Industrial Engineering, Chemical Engineering, or a related field
• At least 8 years of experience in NPI (New Product Introduction) roles within the pharmaceutical or medical device industry
• Proven experience in leading Design Transfer projects and transitioning products to full-scale manufacturing
• Hands-on experience in executing process and equipment validations (IQ/OQ/PQ)
• Experience in managing projects within a matrix organization
• High-level English proficiency – spoken, written, and reading
• Familiarity with quality and regulatory standards such as ISO 13485, GMP, FDA QSR – an advantage