NPI Process Engineer

Datwyler Group; Alken; Sur place; EUR 70 000 - 110 000; Plein temps

Résumé du poste

Datwyler is seeking a New Product Introduction (NPI) Process Engineer in Belgium. You will own end-to-end manufacturing process setup and qualification in a GMP environment, providing technical leadership across functions and sites to drive robust, scalable processes.

You will coordinate process validation strategies (IQ/OQ/PQ/PPQ) and ensure alignment with product specifications, with strong emphasis on cross-functional collaboration and regulatory compliance. Fluent English is required.

Qualifications

• Master’s or PhD in Engineering, Chemistry, Materials Science, or related field.
• 7–10+ years of GMP manufacturing, process development, or NPI.
• Proven experience leading process industrialization and validation.
• Strong knowledge of FDA, EMA, ISO.
• Demonstrated technical leadership and project management.
• Excellent stakeholder management and communication.
• Fluent in English.

Responsabilités

• End-to-End Process Ownership: Design and implement manufacturing processes from development to GMP samples.
• Define process architecture, control strategy, and validation roadmap and execution.
• Ensure alignment between product specs and manufacturing capabilities (DFM).
• Technical Leadership: SME for manufacturing processes in NPI projects; guide teams; review designs.
• Review and approve process designs, validation strategies, and technical docs.
• Project & Stakeholder Management: Interface with Product Line, Quality, Operations, Commercial and external partners.
• Drive alignment on requirements, risks, and execution strategy.
• GMP Compliance & Validation Strategy: Own IQ/OQ/PQ and PPQ validation; ensure regulatory compliance.
• Oversee documentation in collaboration with QA.
• Industrialization & Scale-Up: Lead tech transfer and scale-up; ensure robust, repeatable, cost-efficient processes.
• Manage equipment selection, qualification, and commissioning with stakeholders.
• Risk Management & Continuous Improvement: Lead PFMEA, CAPA, and establish best practices.

Connaissances

GMP manufacturing

Process development

NPI leadership

Regulatory knowledge

Project management

Stakeholder management

English fluency

Formation

Master’s or PhD in Engineering, Chemistry, or Materials Science

Description du poste

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