GMP Validation Specialist — Analytical Methods

Stevanato Group; Piombino Dese; Vor Ort; EUR 32.000 - 39.000; Vollzeit

Benefits dieser Stelle

Health coverage

Canteen services

Welfare platform

Wellbeing initiatives

Language training

Zusammenfassung

Stevanato Group in Italy seeks a Validation Manager to lead qualification and validation activities ensuring GMP-compliant processes and documentation. You will work across QA, Commercial, and R&D to support product quality and analytical methods.

The role requires a scientific Master’s degree with 2+ years in validation within a multinational setting and strong English; IT tools proficiency is expected. This on-site position in Italy offers growth and regulatory exposure.

Qualifikationen

• Master’s degree in a scientific field.
• 2+ years of validation experience in a multinational (pharma/medical devices preferred).
• Knowledge of internal audit processes and techniques.
• Knowledge of applicable regulatory standards and GMP.
• Familiarity with regulatory requirements related to standards.
• Proficiency with IT tools.
• Strong English language skills.

Aufgaben

• Execute qualification and validation activities per the approved plan.
• Assist in defining validation activities to ensure GMP compliance.
• Prepare validation documents and review third-party reports.
• Collaborate with Commercial and R&D teams on validation and process quality.
• Develop, transfer, and validate analytical methods for product/process verification.
• Write and review validation protocols and reports per GMP guidelines.
• Define validation strategies and acceptance criteria for analytical methods.
• Support method transfer between laboratories and manufacturing sites.
• Analyze data and perform statistics to demonstrate method validity.

Kenntnisse

Good English language proficiency

Internal audit knowledge

Regulatory standards knowledge

IT tools proficiency

Ausbildung

Scientific Master’s Degree

Tools

IT Tools

Jobbeschreibung

Stevanato Group in Italy seeks a Validation Manager to lead qualification and validation activities ensuring GMP-compliant processes and documentation. You will work across QA, Commercial, and R&D to support product quality and analytical methods.

The role requires a scientific Master’s degree with 2+ years in validation within a multinational setting and strong English; IT tools proficiency is expected. This on-site position in Italy offers growth and regulatory exposure.