Senior CSV Expert

hace 2 días

Valladolid, Valladolid, España Bacthera Spain, Sl A tiempo completo
Job Description

As a successful CSV Engineer at Bacthera Spain, SL, you will ensure that Computer System Validations are performed according to global and local company policies and standards as well as legal requirements and requirements set by health authorities.

Key Responsibilities
  • Developing CSV Policies / SOP`s and Risk Assessments aligned with applicable regulatory expectations and industry standards
  • Developing of protocols for CSV in accordance with policy and procedures
  • Leading assigned CSV for the process equipment of 4 facilities and providing guidance to local teams
  • Leads and supports CSV projects and related activities for IT supported system
  • Delivery of a complete validation package
  • User Requirements Specification (URS), Validation Plan (VP), Installation/Operational/Performance Qualification Protocol and Execution
  • Traceability Matrix, Validation Summary Report, Configurations Specification
Requirements
  • Bachelor or Master's degree in Engineering, IT, Pharmaceutical Technology, Biotechnology or 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 (Denmark and Switzerland)

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