Process Engineer

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

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

The NPI Process Engineer 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.

Key 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.

What We’re Looking For

• 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, any other language is a plus.

What We Offer

• Attractive compensation package that rewards your expertise and impact.
  • For Italy: pay range 55.800 - 83.700 EUR gross annual base salary
• Flexible working arrangements with hybrid options to support a healthy work-life balance.
• Continuous learning and development opportunities to help you grow your skills and advance your career.
• The chance to work with cutting-edge technologies across exciting, fast-evolving industries.
• A collaborative, high-performing team environment where your ideas and contributions truly make a difference.

The final salary will be determined on factors such as experience, skills, training, location, certifications, education, and any applicable minimum wage requirements. Decisions will be determined on a case-by-case basis.

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.

www.datwyler.com