Validation Specialist

Location: Piombino Dese

At Stevanato Group, what we do matters. Every solution we develop contributes to delivering life‑changing treatments to patients around the world.

In this role, you will play a key part in the  Quality Validation team,   ensuring the approval and validation of all production processes and supporting functions producing a product that meets quality and regulatory requirements.

You will contribute to our ambition to  solve what matters, together , combining technical excellence, collaboration, and a strong sense of ownership.

What You’ll Do
Validation Management

Execute the qualification and validation activities to achieve the validation targets according to the level of services and timing defined in the approved plan, guaranteeing compliance with applicable standards.

Support the leader above in the definition of the qualification and validation activities, aimed at ensuring compliance with the quality management system with applicable standards and requirements.

Provide timely and accurate all the validation documents, monitoring also third parts reports to be reviewed by the leader above for the final submission.

Participate alongside the Commercial Team to carry out new projects ensuring technical assistance and validation, as well as with R&D Team to define appropriate processes to guarantee the quality and reliability of the products.

Support the development, optimization, transfer and validation of analytical test methods used for product, process verification activities.

Author and review analytical method validation protocols and reports in accordance with applicable GMP requirements and international guidelines.

Define validation strategies and acceptance criteria for analytical methods, including assessment of accuracy, precision, specificity, linearity, range, robustness, detection limits and quantification limits.

Support analytical method transfer activities between laboratories and manufacturing sites.

Perform data analysis and statistical evaluation to demonstrate method suitability and maintain the validated state throughout the method lifecycle.

Guidelines and Procedures

Contribute to cascade accurate and up-to-date information related to regulations, customer requirements, and other applicable standards to the team and to the other functions involved into the processes.

Support the validation practices definition, ensuring inclusion within the relevant quality management system.

Provide technical support to other functions involved to ensure the full application of the relevant quality management system for what concerns validations process.

Contribute to the definition and continuous improvement of analytical method validation procedures in compliance with GMP requirements and international guidance (e.g. ICH Q2(R2), ICH Q14 and applicable pharmacopoeia standards).

Quality Audit Management

Participate in the audit sessions as well as during the customers technical meetings to provide accurate and timely technical services and support for the relevant topic, executes corrective and preventive actions assigned

working closely with the involved teams.

Reporting and Monitoring

Elaborate appropriate reports to monitor KPIs related to validation and meet internal and external needs, highlighting timely deviations and critical issues and propose to the leader above actionable initiatives to achieve appropriate and effective resolution.

In This Role, You Are Encouraged To

Take ownership of outcomes, not just tasks

Bring ideas forward and turn them into solutions

Collaborate openly and contribute to shared success

Skills & Experience

Scientific Master’s Degree

+2 years’ experience in Validation in a multinational company (preferably in a pharmaceutical and medical devices company)

Knowledge of the internal audit: process, features techniques

Knowledge of applicable regulatory, standards, global manufacturing practices;

Legal and standard requirements linked to the relevant applicable standard

IT Tool

Good English language proficiency

Mindset & Ways of Working
We Are Looking For People Who

Are curious, hands‑on problem solvers

Thrive in fast‑paced and dynamic environments

Take ownership and accountability

Value…