09 set - Pregnana Milanese
Datwyler Group
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. /p pOur 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... /p h3New Product Introduction (NPI) Process Engineer /h3 pThe 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. /p h3Responsibilities /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 liDefine process architecture, control strategy, and validation roadmap and execution /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 liDrive alignment on requirements, risks, and execution strategy /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 liEnsure processes are robust, repeatable, and cost-efficient /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 liEstablish best practices and standardization across NPI processes /li /ul h3Profile /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 liExcellent stakeholder management and communication skills /li liFluent in English /li /ul h3Be yourself at Datwyler /h3 pWe 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. /p /p #J-18808-Ljbffr
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