Remote Device Industrialization & Lifecycle Lead

Chiesi Farmaceutici S.p.A.; Parma; Hybrid; EUR 52,000 - 65,000; Full time

Benefits offered by this job

Company pension

Private medical insurance

Wellbeing programme

Flexible benefits programme

Relocation support

Annual bonus

Job summary

Chiesi Farmaceutici S.p.A. in Parma, IT, seeks an experienced professional to lead industrialization, validation, and lifecycle management of medical devices and drug-device combinations.

You will drive cross-functional projects with Quality, Engineering, Manufacturing, and external partners, ensuring compliance with regulatory requirements and robust process transfer. The role emphasizes technical leadership, risk assessment, and continuous improvement across multiple sites, with travel to

Qualifications

• 8–10 years in industrialization, validation, and lifecycle management of medical devices and/or drug-device products.
• Strong engineering background with hands-on product development, industrialization, and manufacturing experience.
• Proven experience leading cross-functional technical projects with Quality, Engineering, Manufacturing sites, and external partners.
• Knowledge of regulated environments, validation practices, change management, risk assessment, and Medical Device Regulation requirements.
• Ability to drive technology transfer, scale-up, and process improvements across multiple sites and CMOs.

Responsibilities

• Lead industrialization and scale-up projects for Device Constituent Parts (DCPs) and oversee development, validation, and tech transfer.
• Provide technical leadership for validation, change management, risk assessment, and industrial development across device platforms.
• Coordinate cross-functional projects involving R&D, Quality, Regulatory Affairs, Engineering, Manufacturing Sites, and CMOs.
• Develop, execute, and review validation plans, protocols, reports, and development studies supporting lifecycle management.
• Support investigations, root cause analyses, and corrective actions to ensure product robustness and continuity.
• Oversee assessment and implementation of changes affecting Device Constituent Parts.
• Collaborate with manufacturing sites and partners to align on technical strategies, process improvements, and lifecycle management.
• Assist in preparing technical documentation for regulatory submissions and compliance with Medical Device Regulation requirements.
• Monitor project risks, timelines, and deliverables with governance support.
• Promote continuous improvement to enhance device robustness, manufacturing reliability, and supply continuity.

Skills

Device industrialization

Validation

Lifecycle management

Technical leadership

Project governance

Risk management

Regulatory requirements

Cross-functional collaboration

Quality systems

Process improvement

Job description

Chiesi Farmaceutici S.p.A. in Parma, IT, seeks an experienced professional to lead industrialization, validation, and lifecycle management of medical devices and drug-device combinations.

You will drive cross-functional projects with Quality, Engineering, Manufacturing, and external partners, ensuring compliance with regulatory requirements and robust process transfer. The role emphasizes technical leadership, risk assessment, and continuous improvement across multiple sites, with travel to