NPI Process Engineer – GMP Manufacturing & Tech Leadership

Datwyler Group; Valparaíso; Presencial; CLP 84.349.000 - 131.209.000; Jornada completa

Descripción de la vacante

Datwyler Group is seeking a New Product Introduction (NPI) Process Engineer in Chile to lead end-to-end manufacturing process setup, industrialization and qualification in a GMP environment. You will provide technical leadership across functions to drive technology transfer and scalable processes.

The role requires strong regulatory knowledge (FDA, EMA, ISO), extensive NPI experience, and proven project management. Fluent English and collaboration with global teams are essential.

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.
• Strong knowledge of regulatory frameworks (FDA, EMA, ISO).
• Demonstrated technical leadership and project management capability.
• Excellent stakeholder management and communication skills.
• Fluent in English.

Responsabilidades

• Lead end-to-end design and implementation of manufacturing processes from development to GMP samples.
• Define process architecture, control strategy, and validation roadmap.
• Ensure alignment between product specifications and manufacturing capabilities (Design for Manufacturing).
• Act as SME for manufacturing processes in NPI projects and guide engineering teams.
• Review and approve process designs, validation strategies, and documentation.
• Interface with Product Line, Quality, Operations, Commercial and external partners.
• Own process validation strategy (IQ/OQ/PQ, PPQ) and ensure regulatory compliance.
• Lead technology transfer and scale-up activities; ensure robust, repeatable, cost-efficient processes.
• Lead risk assessments (PFMEA) and CAPA for NPI projects.

Conocimientos

Fluent in English

Stakeholder management

Project management

Educación

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

Descripción del empleo

Datwyler Group is seeking a New Product Introduction (NPI) Process Engineer in Chile to lead end-to-end manufacturing process setup, industrialization and qualification in a GMP environment. You will provide technical leadership across functions to drive technology transfer and scalable processes.

The role requires strong regulatory knowledge (FDA, EMA, ISO), extensive NPI experience, and proven project management. Fluent English and collaboration with global teams are essential.