Process Engineer (Italia)

Process Engineer (Italia)

24 ago
|
Datwyler Group
|
Italia

24 ago

Datwyler Group

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 Engnieer 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, process devel

📌 Process Engineer (Italia)
🏢 Datwyler Group
📍 Italia

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