🚀 Process Engineer - Validazione Processi Medical Devices

General information

Akkodis is a global leader in engineering and R&D, accelerating innovation and digital transformation using connected data.

Company background

With a team of more than 40,000 engineers and digital experts, Akkodis operates in 28 countries across North America, EMEA, and APAC, generating a revenue of €4bn.

Role overview

Process Engineer – Validation of Medical Device Processes

This role is part of our Medical Devices division, contributing to the design, development, and production of medical devices, ensuring compliance with regulatory standards.

Responsibilities

• Validate processes on medical devices in cleanroom and sterilization environments.
• Execute activities related to CSV (Computer Software Validation) and TMV (Test Method Validation).
• Plan and conduct validation tests on product subjected to process validation.
• Interface with R&D V&V Operation to maintain process and product performance.
• Interface with design transfer and industrialization teams to ensure device design transfer to production.

Qualifications

• Master’s degree in Engineering, Life Sciences or related discipline.
• Minimum 2 years of experience as Process Engineer, preferably in the Medical Devices sector.
• Knowledge of validation strategy and management of validation documentation (IQ/OQ/PQ).
• Proficiency with statistical tools: DOE, Gage R&R, Cp/Cpk/Pp/Ppk, sampling plans, preferably using Minitab.
• Experience in Life Sciences.
• Good proficiency in English.
• Basic knowledge of project management.

Benefits and Career Path

A structured and personalized career pathway with opportunities for vertical and transversal growth. Training plans, annual performance reviews, and support from management and HR partners. Access to a corporate benefits platform.

Location

Modena, Italy (Emilia-Romagna)

Employment details

Contract: Permanent full time (24/7). Eligibility: 1 to 3 years of experience. Vacancy: 1