Process Engineer

Location: Pregnana Milanese

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
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.

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