Technical Product & Process Engineer

ppIn 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. p h3New Product Introduction (NPI) Process Engineer /h3 pThe NPI Process Engineer is accountable for the end-to-end setup, industrialization, and qualification of manufacturing processes in a GMP environment. p h3Key Responsibilities /h3 h3End-to-End Process Ownership /h3 ul liLead the design and implementation of complete manufacturing processes from early development until GMP samples (validated process). /li liEnsure alignment between product specifications and manufacturing capabilities (Design for Manufacturing). /li /ul h3Technical Leadership /h3 ul liAct as Subject Matter Expert (SME) for manufacturing processes in NPI projects. /li liProvide guidance and technical decision-making across engineering teams. /li liReview and approve process designs, validation strategies, and technical documentation. /li /ul h3Project Stakeholder Management /h3 ul liInterface with internal stakeholders (Product Line, Quality, Operations, Commercial) and external partners. /li /ul h3GMP Compliance Validation Strategy /h3 ul liOwn process validation strategy (IQ/OQ/PQ, PPQ) and ensure regulatory compliance. /li liOversee documentation in collaboration with Quality experts. /li /ul h3Industrialization Scale-Up /h3 ul liLead technology transfer and support scale-up activities. /li liManages equipment selection, qualification, and commissioning in collaboration with Manufacturing Stakeholders. /li /ul h3Risk Management Continuous Improvement /h3 ul liLead risk assessments (PFMEA) and mitigation strategies. /li liDrive root cause analysis and CAPA for critical issues part of NPI projects. /li /ul h3What We’re Looking For /h3 ul liMaster’s or PhD in Engineering, Chemistry, Materials Science, or related field. /li li7-10+ years of experience in GMP manufacturing, process development, or NPI. /li liProven experience leading process industrialization and validation. /li liStrong knowledge of regulatory frameworks (FDA, EMA, ISO). /li liDemonstrated technical leadership and project management capability. /li liFluent in English, any other language is a plus. /li /ul h3What We Offer /h3 ul liAttractive compensation package that rewards your expertise and impact. ul liFor Italy: pay range Visualizzare il telefono su click.jobroute.io EUR gross annual base salary /li /ul /li liFlexible working arrangements with hybrid options to support a healthy work-life balance. /li liContinuous learning and development opportunities to help you grow your skills and advance your career. /li liThe chance to work with cutting-edge technologies across exciting, fast-evolving industries. /li /ul pThe final salary will be determined on factors such as experience, skills, training, location, certifications, education, and any applicable minimum wage requirements. 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. /