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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
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Bavarian Nordic Berna GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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