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Date: Jul 31, 2026
Location: Alken, BE, 3570 Karlsbad-Ittersbach, DE, 76307 Pregnana Milanese, IT, 20010
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Company: Datwyler
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.
Responsibilities
End-to-End Process Ownership
Lead 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 execution
Ensure alignment between product specifications and manufacturing capabilities (Design for Manufacturing)
Technical Leadership
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
Drive alignment on requirements, risks, and execution strategy
GMP Compliance & Validation Strategy
Own process validation strategy (IQ/OQ/PQ, PPQ) and ensure regulatory compliance
Oversee documentation in collaboration with Quality experts
Industrialization & Scale-Up
Lead technology transfer and support scale-up activities
Ensure processes are robust, repeatable, and cost-efficient
Manages equipment selection, qualification, and commissioning in collaboration with Manufacturing Stakeholders
Risk Management & Continuous Improvement
Lead risk assessments (PFMEA) and mitigation strategies
Drive root cause analysis and CAPA for critical issues part of NPI projects
Establish best practices and standardization across NPI processes
Profile
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
Excellent stakeholder management and communication skills
Fluent in English
Be yourself at Datwyler
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.
www.datwyler.com
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