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Validation Engineer for Computer Systems

2 mesi fa

Milano, Lombardia, Italia NTT DATA A tempo pieno

Position Overview

We are seeking a skilled Computer System Validation Engineer to join our dynamic Life Sciences Team at NTT DATA. This role involves engaging in various phases of the validation lifecycle, ensuring that IT systems comply with GxP regulations while meeting customer requirements.

Key Responsibilities:

  • Contribute to the formulation of validation strategies and assist in the specification and design of system integrations.
  • Act as a technical liaison among different stakeholders, including system developers, software engineers, and end-users.
  • Analyze and interpret requests for changes to existing systems.
  • Conduct Data Integrity Risk Assessments for all computerized and automated systems.
  • Identify and evaluate potential risks related to quality and compliance.
  • Provide quality assurance oversight during validation processes.
  • Develop and review documentation, including training materials, standard operating procedures (SOPs), and change controls, ensuring adherence to GMP and relevant regulatory standards.
  • Create and implement comprehensive validation documentation, such as Validation Plans, Validation Summary Reports, Risk Assessments, and Installation/Operational Qualification (IOQ) protocols.

Qualifications:

  • Master's degree in IT, Computer Science, Industrial Engineering, Biotechnology, Chemistry, or Pharmacy.
  • Previous experience in IT and Computer System Validation roles is advantageous.
  • Familiarity with GMP environments and the validation lifecycle.
  • Strong ability to comprehend and extract essential information from technical documentation.
  • Excellent teamwork and organizational skills, with a strong emphasis on analytical capabilities.
  • Effective communication skills, both verbal and written, in English.

Join us in our mission to deliver innovative solutions in the Life Sciences sector.