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BABavarian Nordic Berna GmbH

Senior Computer System Validation Engineer(m/w/x)

Bern
Full-timeOn-siteSenior
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Computer system validation and data integrity assessments for global vaccine development. 5+ years of CSV experience in biotech industry required. 12-month parental cover, international company exposure.

Requirements

  • BS/MSc in IT, Computer Science or equivalent
  • Strong track record in Biotech-Industry
  • Minimum 5 years of experience in CSV related field
  • Project management experience
  • English, oral and written
  • German is a plus
  • Technical/Lifecycle Documentation creation/execution
  • System Validation: commissioning and qualification
  • Ability to lead and manage CSV and OT projects
  • Comprehensive understanding of GMP, FDA, GAMP5
  • Audit participation experience

Tasks

  • Review and approve CSV and OT lifecycle documentation
  • Conduct periodic computer system reviews
  • Perform data integrity assessments
  • Execute risk and gap assessments
  • Implement risk mitigation activities
  • Commission and qualify software and equipment
  • Lead deviation investigations
  • Manage change control processes
  • Handle CAPA management
  • Support CSV-related projects and site changes
  • Provide risk management expertise
  • Assist engineering, R&D, quality, and manufacturing as a CSV expert

Work Experience

  • 5 years

Education

  • Master's degree

Languages

  • English – Business Fluent
  • German – Basic

Tools & Technologies

  • URS
  • FDS
  • HDS
  • Commissioning
  • Qualification Protocols/Reports
  • Data Flow Diagrams
  • Periodic Review Reports
  • Data Integrity Assessment
  • Risk/GAP Assessment Reports
  • GMP
  • FDA
  • GAMP5

Benefits

Generous Parental Leave

  • Parental cover for 12 months

Informal Culture

  • Opportunity to be part of an international company

Modern Equipment

  • Exceptional technology

Other Benefits

  • Determined team

Startup Environment

  • Vibrant and adaptable work environment

Learning & Development

  • Support for personal and professional skills growth
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