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

Required Qualifications:

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