Senior CSV Specialist

hace 2 días


Valladolid, Valladolid, España Bacthera Spain A tiempo completo
Job Title: Senior CSV Expert

As a Senior CSV Expert at Bacthera Spain, you will play a crucial role in ensuring the quality and compliance of our Computer System Validations. Your expertise will be instrumental in planning, developing, and executing CSVs for our facilities, while also developing policies, SOPs, and risk assessments aligned with regulatory expectations and industry standards.

Key Responsibilities:
  • Develop and implement CSV policies, SOPs, and risk assessments
  • Lead CSV projects and provide guidance to local teams
  • Coordinate with stakeholders to ensure accurate and timely completion
  • Perform system reviews and analyze related deviations, CAPAs, and changes
  • Collaborate with system Admin and IT to follow up on changes and incidents
Requirements:
  • Bachelor or Master's degree in Engineering, IT, Pharmaceutical Technology, Biotechnology, or related field
  • Minimum 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
What We Offer:
  • Start-up and innovative company with a fast decision environment
  • Flexible working hours and international team
  • Attractive salary and languages courses offered

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