Device Industrial Development Senior Specialist

Business Area: Industrial Operations & HSE

Job Type: Direct Employee

Contract Type: Permanent

Location: parma, IT

Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here.

At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.

Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.

Global Technical Operations & Supply (Global TechOp&S) is Chiesi’s global manufacturing and supply area, responsible for ensuring consistent, outstanding quality, service and value across our end‑to‑end supply chain. Global TechOp&S oversees the entire lifecycle of the drug: from process optimization and industrialization, to manufacturing, engineering, quality oversight, and supply chain management. Throughout this journey, Operational Excellence drives continuous improvement. This end‑to‑end model is powered by our four manufacturing sites - Parma (IT), Blois (FR), Santana de Parnaíba (BR), and Nerviano (IT) - together with our Virtual Plant network of external partners.

This is what you will do

Ensure the successful delivery of DCP/Device lifecycle management, scale‑up and industrialisation activities by providing technical leadership, project governance and oversight of validation, change implementation and risk management processes. Drive alignment across internal functions, external partners and manufacturing sites to secure compliance and business continuity.

You will be responsible for

• Lead industrialization and scale‑up projects for Device Constituent Parts (DCPs), coordinating cross‑functional activities and ensuring the successful execution of development, validation, and technology transfer activities.
• Provide technical leadership for validation, change management, risk assessment, and industrial development activities across device platforms.
• Manage and coordinate cross‑functional projects involving R&D, Quality, Regulatory Affairs, Engineering, Manufacturing Sites, and CMOs.
• Drive the preparation, execution, and review of validation plans, technical protocols, reports, and development studies supporting industrialization and lifecycle management initiatives.
• Support problem‑solving investigations, root cause analyses, and the implementation of corrective actions to ensure product robustness and business continuity.
• Oversee the assessment and implementation of changes affecting Device Constituent Parts.
• Collaborate with manufacturing sites and external partners to ensure alignment on technical strategies, process improvements, scale‑up activities, and lifecycle management initiatives.
• Contribute to the preparation of technical documentation required to support regulatory submissions and compliance with Medical Device Regulation requirements.
• Monitor project risks, timelines, and deliverables, providing technical guidance and governance to support successful project execution.
• Promote continuous improvement initiatives aimed at enhancing device robustness, manufacturing reliability, supply continuity, and operational excellence.

You will need to have

• 8 -10 years in the industrialization, validation, and lifecycle management of medical devices and/or drug‑device combination products.
• Strong engineering background and technical expertise combined with hands‑on experience in product development, industrialization, and manufacturing.
• Proven experience in leading cross‑functional technical projects involving Quality, Engineering, Manufacturing Sites, and external partners.
• Strong understanding of regulated environments, including validation practices, change management, risk assessment, and Medical Device Regulation requirements.
• Demonstrated ability to support industrialization, scale‑up, technology transfer, and process improvement activities across multiple manufacturing sites and CMOs.
• Ability to translate technical data into sound recommendations and support decision‑making across multidisciplinary teams.