NPI Process Engineer - GMP Manufacturing & Validation

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

Résumé du poste

Datwyler is seeking an NPI Process Engineer to own end-to-end manufacturing development, industrialization, and qualification in a GMP environment. You will lead cross-functional teams, define validation roadmaps, and ensure manufacturing capabilities align with product specs.

You will act as SME for NPI processes, guide design decisions, manage projects with internal and external partners, and drive risk assessments, CAPA, and technology transfer to scale-up activities.

Qualifications

• Master's or PhD in Engineering, Chemistry, Materials Science, or related field.
• 7-10+ years in GMP manufacturing, process development or NPI.
• Experience leading process industrialization and validation.
• Knowledge of FDA, EMA, ISO regulatory frameworks.
• Demonstrated leadership and project management capability.

Responsabilités

• End-to-End Process Ownership: design and implement manufacturing processes from development to GMP samples.
• Technical Leadership: SME for manufacturing processes in NPI projects and cross-functional guidance.
• Project & Stakeholder Management: align requirements, risks and execution with internal/external partners.
• GMP Compliance & Validation Strategy: own IQ/OQ/PQ/PPQ, ensure regulatory compliance.
• Risk Management & Continuous Improvement: conduct PFMEA, CAPA, drive standardization.

Connaissances

Technical leadership

Project management

Stakeholder management

Communication

Risk assessment

Formation

Master's or PhD in Engineering, Chemistry, Materials Science (or related)

Description du poste

Datwyler is seeking an NPI Process Engineer to own end-to-end manufacturing development, industrialization, and qualification in a GMP environment. You will lead cross-functional teams, define validation roadmaps, and ensure manufacturing capabilities align with product specs.

You will act as SME for NPI processes, guide design decisions, manage projects with internal and external partners, and drive risk assessments, CAPA, and technology transfer to scale-up activities.