Process Engineer
Pubblicato il 01-10-2026 - Datwyler Group in Italia
In billions of syringes and in every second car worldwide, Datwyler components make an important contribution to the safety of patients and drivers. The high-tech company focuses on high-quality, system-critical elastomer components and holds leading positions in attractive global markets such as healthcare, mobility, connectivity, general industry and food & beverage. With over 25 production sites on four continents, sales in more than 100 countries and over 8,000 employees, the company, headquartered in Switzerland, generates annual sales of more than CHF 1,000 million.
We have strong roots and values that have been well established in our 100-year corporate history. New Product Introduction (NPI) Process Engineer
The NPI Process Engineer is accountable for the end-to-end setup, industrialization, and qualification of manufacturing processes in a GMP environment. Lead the design and implementation of complete manufacturing processes from early development until GMP samples (validated process).
Ensure alignment between product specifications and manufacturing capabilities (Design for Manufacturing).
Act as Subject Matter Expert (SME) for manufacturing processes in NPI projects.
Provide guidance and technical decision-making across engineering teams.
Review and approve process designs, validation strategies, and technical documentation.
Project & Stakeholder Management
Interface with internal stakeholders (Product Line, Quality, Operations, Commercial) and external partners.
GMP Compliance & Validation Strategy
Own process validation strategy (IQ/OQ/PQ, PPQ) and ensure regulatory compliance.
Oversee documentation in collaboration with Quality experts.
Manages equipment selection, qualification, and commissioning in collaboration with Manufacturing Stakeholders.
Drive root cause analysis and CAPA for critical issues part of NPI projects.
Master’s or PhD in Engineering, Chemistry, Materials Science, or related field.
~7–10+ years of experience in GMP manufacturing, pr