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.

• 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