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.Our employees are the heart of Datwyler - we treat each other with respect, trust and appreciation. We have strong roots and values that have been well established in our 100-year corporate history. Become part of our great team as a... New Product Introduction (NPI) Process Engineer Goal The NPI Process Engnieer is accountable for the end-to-end setup, industrialization, and qualification of manufacturing processes in a GMP environment. The role provides technical leadership, coordination, and strategic direction for NPI activities across functions and sites.ResponsibilitiesEnd-to-End Process OwnershipLead the design and implementation of complete manufacturing processes from early development until GMP samples (validated process)Define process architecture, control strategy, and validation roadmap and executionEnsure alignment between product specifications and manufacturing capabilities (Design for Manufacturing)Technical LeadershipAct as Subject Matter Expert (SME) for manufacturing processes in NPI projectsProvide guidance and technical decision-making across engineering teamsReview and approve process designs, validation strategies, and technical documentationProject & Stakeholder ManagementInterface with internal stakeholders (Product Line, Quality, Operations, Commercial) and external partnersDrive alignment on requirements, risks, and execution strategyGMP Compliance & Validation StrategyOwn process validation strategy (IQ/OQ/PQ, PPQ) and ensure regulatory complianceOversee documentation in collaboration with Quality expertsIndustrialization & Scale-UpLead technology transfer and support scale-up activitiesEnsure processes are robust, repeatable, and cost-efficientManages equipment selection, qualification, and commissioning in collaboration with Manufacturing StakeholdersRisk Management & Continuous ImprovementLead risk assessments (PFMEA) and mitigation strategiesDrive root cause analysis and CAPA for critical issues part of NPI projectsEstablish best practices and standardization across NPI processes Profile Master’s or PhD in Engineering, Chemistry, Materials Science, or related field7–10+ years of experience in GMP manufacturing, process development, or NPIProven experience leading process industrialization and validationStrong knowledge of regulatory frameworks (FDA, EMA, ISO)Demonstrated technical leadership and project management capabilityExcellent stakeholder management and communication skillsFluent in EnglishBe yourself at DatwylerWe are convinced that people make the difference. At Datwyler, you will experience diversity and a wide range of career opportunities that only an international company can provide. Together, we are increasing our agility, accelerating digitalization and fostering sustainability. 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.www.datwyler.com

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NPI Process Engineer