NPI Process Engineer - GMP Manufacturing Leader

Datwyler Group; Pregnana Milanese; Ibrido; EUR 56.000 - 84.000; Tempo pieno

Vantaggi offerti da questo lavoro

Hybrid work arrangements

Learning & development opportunities

Exposure to cutting-edge technologies

Collaborative, high-performing team

Descrizione del lavoro

Datwyler is seeking a New Product Introduction (NPI) Process Engineer to own end-to-end manufacturing process setup, industrialization and validation in a GMP environment. You will provide technical leadership across sites, manage cross-functional projects, and drive robust, scalable processes with a focus on quality and regulatory compliance.

The role requires 7–10+ years in GMP manufacturing or NPI, with strong tracking in process validation and regulatory knowledge.

Competenze

• 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.
• Strong knowledge of regulatory frameworks (FDA, EMA, ISO).
• Demonstrated technical leadership and project management capability.
• Excellent stakeholder management and communication skills.
• Fluent in English; other languages are a plus.

Mansioni

• End-to-End Process Ownership: design and implement complete manufacturing processes from development to GMP samples.
• Technical Leadership: act as SME for manufacturing processes in NPI projects and guide engineering teams.
• Project & Stakeholder Management: interface with Product Line, Quality, Operations, Commercial and external partners.
• GMP Compliance & Validation Strategy: own IQ/OQ/PQ/PPQ validation and ensure regulatory compliance.
• Industrialization & Scale-Up: lead technology transfer and scale-up activities; ensure robust, cost-efficient processes.
• Risk Management & Continuous Improvement: conduct PFMEA, root cause analysis, CAPA, and standardize NPI processes.

Conoscenze

GMP manufacturing

Process development

NPI leadership

Regulatory knowledge

Stakeholder management

English fluency

Formazione

Master’s or PhD in Engineering/Chemistry/Materials Science

Descrizione del lavoro

Datwyler is seeking a New Product Introduction (NPI) Process Engineer to own end-to-end manufacturing process setup, industrialization and validation in a GMP environment. You will provide technical leadership across sites, manage cross-functional projects, and drive robust, scalable processes with a focus on quality and regulatory compliance.

The role requires 7–10+ years in GMP manufacturing or NPI, with strong tracking in process validation and regulatory knowledge.