Senior CSV Expert

hace 2 meses

León, España Bacthera Spain, SL A tiempo completo

As a successful CSV Engineer you 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. You are responsible for planning, developing and executing Computer System Validations for 4 Facilities. You will report to the global Head of Engineering Quality

Tareas

  • 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

  • Coordinating the cooperation between other system stakeholders (e.g. IT, Suppliers, etc.) including the alignment of Service Level needed

  • Coordinating/Handling the CSV tasks

  • Follow up changes and incidents for GMP/CSV relevant systems in collaboration with system Admin and IT

  • Performing the yearly system review for each system

  • Reviewing and analyzing related Deviations, CAPAs and Changes

  • Coordinating and communicating with stakeholders to ensure accurate and timely completion

Requisitos
  • 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)
Beneficios

Start-up and innotative company within a fast decission environment

Flexible working hours (on site)

International and highly motivated team

Atractive salary

Languages courses offered

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