Global Validation Expert

Boehringer Ingelheim

Industria farmacéutica

Sant Cugat del Vallès, Cataluña - Spanien

Project Manager Sénior / Especialista sénior

Híbrido

Experteer Overview

As Global Validation Expert you will drive validation of IT systems used for laboratory instrument integration and data management. You’ll shape validation strategies and ensure compliance across global systems, supporting audits and inspections. You collaborate with cross‑functional teams to improve internal processes and enable digital transformation in the lab domain. This role offers impact on quality, compliance, and broader industry innovation. You will work in a fast‑paced, compliance‑driven environment with strong technical stakeholders.

Compensaciones / Beneficios

Flexible working conditions
Life and accident insurance
Health insurance at a competitive price
Investment in learning and development
Gym membership discounts

Responsabilidades

Develop Validation Strategies: create, implement and timeline validation activities
Support Validation Activities: oversee testing, review protocols, ensure adherence to strategies
Ensure Compliance with Regulations: validate systems per regulations and adjust strategies as needed
Documentation and Reporting: maintain records, prepare reports, log issues and resolutions
Training and Development: participate in validation training and coach the team

Requisitos principales

Bachelor's degree in IT, Bioinformatics, Medicinal Informatics, or similar
Minimum 4 years in computer systems validation management or related field
Extensive experience creating validation concepts for global systems from ground up
Audits and inspections representation of systems
Technical understanding of hardware, software and network systems
Regulatory knowledge of FDA 21 CFR Part 11 and EU Annex 11
Strong documentation skills
English and Spanish language skills (additional languages a plus)

Effective communication with team members and stakeholders Attention to detail and thoroughness in documentation Cross‑functional collaboration Validation concepts for global IT systems Knowledge of computer systems validation management Understanding of hardware, software, and network systems

Descripción del puesto

As Global Validation Expert you will drive validation of IT systems used for laboratory instrument integration and data management. You’ll s…

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