NPI Process Engineer

NPI Process Engineer

Datwyler

Alken, Karlsbad or Pregnana Milanese

Responsibilities

End-to-End Process Ownership

• 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)

Technical Leadership

• Act as Subject Matter Expert (SME) for manufacturing processes in NPI projects
• Provide guidance and technical decision-making across engineering teams
• Review and approve process designs, validation strategies, and technical documentation

Project & Stakeholder Management

• Interface with internal stakeholders (Product Line, Quality, Operations, Commercial) and external partners
• Drive alignment on requirements, risks, and execution strategy

GMP Compliance & Validation Strategy

• Own process validation strategy (IQ/OQ/PQ, PPQ) and ensure regulatory compliance
• Oversee documentation in collaboration with Quality experts

Industrialization & Scale-Up

• Lead technology transfer and support scale-up activities
• Ensure processes are robust, repeatable, and cost-efficient
• Manages equipment selection, qualification, and commissioning in collaboration with Manufacturing Stakeholders

Risk Management & Continuous Improvement

• Lead risk assessments (PFMEA) and mitigation strategies
• Drive root cause analysis and CAPA for critical issues part of NPI projects
• Establish best practices and standardization across NPI processes

Profile

• 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