Device Industrial Development Senior Specialist

Chiesi Group; Parma; Hybrid; EUR 52,000 - 65,000; Full time

Benefits offered by this job

Annual bonus

Company pension

Private medical insurance

Wellbeing programme

Flexible benefits

Job summary

Chiesi Group is seeking a seasoned professional to lead industrialization, validation, and lifecycle management for device components and drug-device combinations. You will drive cross-functional programs across R&D, Quality, Regulatory, Engineering, and CMOs to ensure robust processes and timely delivery.

Based in Parma with regular travel to sites, you will guide validation activities, risk assessments, and technology transfer while aligning with ISO 13485 and other global regulatory

Qualifications

• 8–10 years in industrialization, validation, and lifecycle management of medical devices and/or drug-device combinations.
• Strong engineering background with hands-on product development and manufacturing experience.
• Proven ability to lead cross-functional technical projects with Quality, Engineering, Manufacturing Sites, and external partners.
• Experience in regulated environments with validation, change management, risk assessment, and regulatory frameworks (ISO 13485, ISO 14971, cGMP).

Responsibilities

• Lead industrialization and scale-up projects for Device Constituent Parts (DCPs) and coordinate development, validation, and technology transfer.
• Provide technical leadership for validation, change management, risk assessment, and industrial development across device platforms.
• Manage cross-functional projects involving R&D, Quality, Regulatory Affairs, Engineering, Manufacturing Sites, and CMOs.
• Prepare, execute, and review validation plans, protocols, reports, and development studies supporting lifecycle initiatives.
• Support investigations, root-cause analyses, and implement corrective actions for robustness and continuity.
• Oversee changes affecting Device Constituent Parts and align with manufacturing sites and partners.
• Contribute to regulatory documentation and compliance for submissions.
• Monitor risks, timelines, and deliverables with governance for successful execution.
• Promote continuous improvement for device robustness, manufacturing reliability, and supply continuity.

Skills

Engineering background

Cross-functional leadership

Regulatory & quality knowledge

Project governance

Data-driven decision making

Education

Bachelor's degree in engineering

Job description

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 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.
• Effective stakeholder management and communication skills, with the ability to build constructive relationships across functions and external partners.
• Strong analytical and problem‑solving capabilities, including experience in investigations, root‑cause analysis, and implementation of corrective actions.
• Ability to balance technical, quality, regulatory, timeline, and business considerations when managing complex projects and changes.
• A collaborative mindset, with the ability to work effectively in matrix organizations and influence outcomes.
• Expertise in medical device quality, risk management, manufacturing, and regulatory frameworks, including ISO 13485, ISO 14971, cGMP, and related global regulatory requirements.
• Fluent in written and spoken English.

Location

The role is based in Parma. Remote working is possible with regular presence in Parma

Availability for regular travel to manufacturing sites and external partners.

Budgeted Salary Range

The budgeted salary range approved for this role is between €52.240 and €65.300. This range reflects the typical compensation expected for candidates with the experience and expertise required for the position.

Final offer may vary based on the selected candidate's skills, experience, qualifications, overall profile, and internal equity considerations.

This role is eligible to participate in an annual bonus scheme, subject to company and individual performance.

In addition, we offer a comprehensive benefits package including company pension, private medical insurance, wellbeing programme, flexible benefits programme…

What we offer

No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way.

We provide top‑class benefits, including comprehensive healthcare programs, work‑life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.

Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.