NPI Process Engineer: GMP Validation & Tech Transfer

Datwyler; Alken; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Datwyler Belgium is seeking an experienced NPI Process Engineer to own end-to-end setup, industrialization, and qualification of manufacturing processes in a GMP environment. You will provide technical leadership, coordinate across sites, and steer NPI activities with cross-functional teams.

With 7–10+ years in GMP manufacturing, you will lead process industrialization, validation, and tech transfer, ensuring robust, compliant, and cost-efficient processes across the organization.

Qualifications

• Master’s or PhD in Engineering, Chemistry, Materials Science, or related field.
• 7–10+ years of GMP manufacturing, process development, or NPI experience.
• 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.

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 specifications and manufacturing capabilities (Design for Manufacturing).
• Act as SME for manufacturing processes in NPI projects; provide guidance across teams.
• Review and approve process designs, validation strategies, and technical documentation.
• Interface with internal stakeholders and external partners; drive alignment on requirements and risks.
• Own process validation strategy (IQ/OQ/PQ, PPQ) and ensure regulatory compliance.
• Lead technology transfer and support scale-up activities; ensure robustness and cost-efficiency.
• Lead risk assessments (PFMEA) and CAPA for NPI projects; drive standardization.

Connaissances

Technical leadership

Project management

Stakeholder management

Communication skills

Formation

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

Description du poste

Datwyler Belgium is seeking an experienced NPI Process Engineer to own end-to-end setup, industrialization, and qualification of manufacturing processes in a GMP environment. You will provide technical leadership, coordinate across sites, and steer NPI activities with cross-functional teams.

With 7–10+ years in GMP manufacturing, you will lead process industrialization, validation, and tech transfer, ensuring robust, compliant, and cost-efficient processes across the organization.