NPI Process Engineer — GMP Manufacturing & Tech Transfer

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

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.