About this role
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.
Responsibilities
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End-to-End Process Ownership
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Lead the design and implementation of complete manufacturing processes from early development until GMP samples (validated process)
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Define process architecture, control strategy, and validation roadmap and execution
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Ensure alignment between product specifications and manufacturing capabilities (Design for Manufacturing)
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Technical Leadership
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Act as Subject Matter Expert (SME) for manufacturing processes in NPI projects
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Provide guidance and technical decision-making across engineering teams
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Review and approve process designs, validation strategies, and technical documentation
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Project & Stakeholder Management
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Interface with internal stakeholders (Product Line, Quality, Operations, Commercial) and external partners
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Drive alignment on requirements, risks, and execution strategy
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GMP Compliance & Validation Strategy
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Own process validation strategy (IQ/OQ/PQ, PPQ) and ensure regulatory compliance
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Oversee documentation in collaboration with Quality experts
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Industrialization & Scale-Up
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Lead technology transfer and support scale-up activities
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Ensure processes are robust, repeatable, and cost-efficient
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Manages equipment selection, qualification, and commissioning in collaboration with Manufacturing Stakeholders
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Risk Management & Continuous Improvement
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Lead risk assessments (PFMEA) and mitigation strategies
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Drive root cause analysis and CAPA for critical issues part of NPI projects
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Establish best practices and standardization across NPI processes
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Profile
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Master’s or PhD in Engineering, Chemistry, Materials Science, or related field
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7–10+ years of experience in GMP manufacturing, process development, or NPI
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Proven experience leading process industrialization and validation
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Strong knowledge of regulatory frameworks (FDA, EMA, ISO)
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Demonstrated technical leadership and project management capability
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Excellent stakeholder management and communication skills
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Fluent in English
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Be yourself at Datwyler
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We 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.