Senior CSV Expert

hace 1 semana


Leganés, Madrid, España Bacthera Spain, Sl A tiempo completo

Job Summary

We are seeking a highly skilled CSV Validation Specialist to join our team at Bacthera Spain, SL. As a CSV Validation Specialist, you will play a critical role in ensuring the quality and integrity of our computer systems.

Key Responsibilities

  • Develop and execute Computer System Validations for 4 facilities, ensuring compliance with global and local company policies, standards, and regulatory requirements.
  • Plan, develop, and execute CSV policies, SOPs, and risk assessments aligned with applicable regulatory expectations and industry standards.
  • Lead assigned CSV projects and provide guidance to local teams, ensuring timely and accurate completion.
  • Coordinate and communicate with stakeholders to ensure accurate and timely completion of CSV tasks.
  • Review and analyze related deviations, CAPAs, and changes, and perform yearly system reviews for each system.

Requirements

  • Bachelor or Master's degree in Engineering, IT, Pharmaceutical Technology, Biotechnology, or a related field.
  • A minimum of 5 years of experience in CSV, MES, SCADA, and OT systems.
  • Good understanding of manufacturing processes and related process equipment.
  • Extensive experience in a regulated pharmaceutical environment and GMP requirements.
  • Ability to prioritize and manage work to critical project timelines in a fast-paced environment.
  • Structured, focused, and well-organized working attitude.
  • Independent way of working and taking ownership of assigned tasks.
  • Working knowledge of quality systems and regulatory requirements across multiple health authorities.
  • Proficient in Spanish and English.
  • Ability to travel occasionally to different sites.

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