Process Engineer

Datwyler; Alken; On-site; EUR 90,000 - 120,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Technical leadership

Project management

Stakeholder management

Communication

Risk assessment

Education

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

Job description

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In billions of syringes and in every second car worldwide, Datwyler components make an important contribution to the safety of patients and drivers. The high-tech company focuses on high-quality, system-critical elastomer components and holds leading positions in attractive global markets such as healthcare, mobility, connectivity, general industry and food & beverage. With over 25 production sites on four continents, sales in more than 100 countries and over 8,000 employees, the company, headquartered in Switzerland, generates annual sales of more than CHF 1,000 million.

Our employees are the heart of Datwyler - we treat each other with respect, trust and appreciation. We have strong roots and values that have been well established in our 100-year corporate history. Become part of our great team as a...

New Product Introduction (NPI) Process Engineer

Goal

The NPI Process Engnieer is accountable for the end-to-end setup, industrialization, and qualification of manufacturing processes in a GMP environment. The role provides technical leadership, coordination, and strategic direction for NPI activities across functions and sites.

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
• Lead technology transfer and support scale-up activities
• Ensure processes are robust, repeatable, and cost-efficiency
• 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

Be yourself at Datwyler

We are convinced that people make the difference. At Datwyler, you will experience diversity and a wide range of career opportunities that only an international company can provide. Together, we are increasing our agility, accelerating digitalization and fostering sustainability. For motivated and talented employees, we offer interesting development opportunities with training and assignments in a global environment. With us, you can contribute with all of your creativity and all your ideas.