NPI Process Engineer: GMP Manufacturing & Validation

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 to lead end-to-end manufacturing process setup in a GMP environment. You will drive industrialization, validation, and technology transfer across functions and sites, ensuring robust, cost-efficient processes.

You bring a Master’s or PhD in engineering or related field, 7–10+ years in GMP manufacturing, and strong leadership and stakeholder management.

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

Responsabilités

• 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 SME for manufacturing processes in NPI projects and provide guidance across engineering teams.
• Interface with internal stakeholders and external partners to align requirements and strategy.
• Own process validation strategy (IQ/OQ/PQ, PPQ) and ensure regulatory compliance.

Connaissances

GMP manufacturing

Process development

NPI leadership

Project management

Regulatory knowledge

Stakeholder management

English fluency

Formation

Master’s or PhD in Engineering/related field

Outils

IQ/OQ/PQ validation

Description du poste

Datwyler is seeking a New Product Introduction (NPI) Process Engineer in Belgium to lead end-to-end manufacturing process setup in a GMP environment. You will drive industrialization, validation, and technology transfer across functions and sites, ensuring robust, cost-efficient processes.

You bring a Master’s or PhD in engineering or related field, 7–10+ years in GMP manufacturing, and strong leadership and stakeholder management.