Senior NPI Process Engineer – GMP Manufacturing

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

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,