CQV / Commissioning Qualification Validation Engineer – Italy

Resourcing Life Science; Cuneo; In loco; EUR 35.000 - 50.000; Tempo pieno

Descrizione del lavoro

Une entreprise renommée dans le domaine des sciences de la vie recherche un spécialiste en Qualification et Validation pour rejoindre leur équipe. Le candidat idéal aura une solide expérience technique, sera responsable de la mise en service des systèmes et de la documentation des résultats de qualification, tout en garantissant la conformité avec les normes de l'industrie.

Competenze

• 2-3 ans d'expérience technique en CQV.
• Connaissance des réglementations industrielles (FDA, GMP, GAMP).
• Excellentes compétences en dépannage et résolution de problèmes.

Mansioni

• Planifier et exécuter des activités de mise en service.
• Créer des plans de qualification détaillés et des protocoles pour l'équipement de production.
• Effectuer des vérifications d'installation, opérationnelles et de performance.

Conoscenze

Troubleshooting

Problem-solving

Technical knowledge

English proficiency

Descrizione del lavoro

• Work closely with engineering teams to plan and execute commissioning activities.
• Create detailed commissioning plans, protocols, and reports for production equipment and room qualifications.
• Conduct thorough checks to ensure equipment and systems are fully functional.
• Quickly identify and resolve issues that arise during commissioning.
• Develop qualification protocols and comprehensive test plans for equipment, systems, and processes.
• Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Maintain meticulous documentation of qualification tests and analyze results.
• Identify and correct any deviations from established specifications.
• Work with cross-functional teams to resolve validation discrepancies.
• Create and implement validation protocols for processes and systems, ensuring compliance with industry standards.

Qualifications

• 2-3 years of technical experience as a CQV
• Strong knowledge of industry regulations (FDA, GMP, GAMP).
• Excellent troubleshooting and problem-solving skills.
• Very good English language skills, both written and spoken.

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