Process Engineer

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, process development, or NPI. ~ Proven experience leading process industrialization and validation. ~ Strong knowledge of regulatory frameworks (FDA, EMA, ISO). ~ Demonstrated technical leadership and project management capability. ~ Fluent in English, any other language is a plus. For Italy: pay range 55.800 – 83.700 EUR gross annual base salary The final salary will be determined on factors such as experience, skills, training, location, certifications, education, and any applicable minimum wage requirements. Flexible working arrangements with hybrid options to support a healthy work-life balance. Continuous learning and development opportunities to help you grow your skills and advance your career. The chance to work with cutting-edge technologies across exciting, fast-evolving industries. At Datwyler, you will experience diversity and a wide range of career opportunities that only an international company can provide. For motivated and talented employees,

we offer
interesting development opportunities with training and assignments in a global environment. With us, you can contribute with all of your creativity and all your ideas.