NPI Process Engineer

Datwyler Group; Valparaíso; Presencial; CLP 55.504.000 - 83.256.000; Jornada completa

Descripción de la vacante

Datwyler is seeking a New Product Introduction (NPI) Process Engineer to lead end-to-end manufacturing process setup, industrialization, and validation in a GMP environment. The role provides technical leadership across sites and functions to drive robust, compliant processes from development through validated production.

You will own process architecture, validation roadmaps, risk assessments, and technology transfer, collaborating with Product, Quality, and Operations teams to ensure scalable,

Formación

• 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.

Responsabilidades

• 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).
• 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.
• Interface with internal stakeholders (Product Line, Quality, Operations, Commercial) and external partners.
• Drive alignment on requirements, risks, and execution strategy.
• Own process validation strategy (IQ/OQ/PQ, PPQ) and ensure regulatory compliance.
• Oversee documentation in collaboration with Quality experts.
• 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.
• 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.

Conocimientos

Process engineering

GMP manufacturing

Project management

Stakeholder management

Regulatory knowledge

Leadership

English language

Educación

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

Descripción del empleo

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