Senior Device Industrialization & Validation Lead

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 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