Join us in Bern as we open a new production site and shape new ways of working. Here, you help set high quality standards and make sure our pharmaceutical products are safe and effective. Whether you have years of experience, are moving from academia, or come from a related industry, you can make a real impact and help us grow.

Deine Aufgaben

  • Develop, review, and approve Computer System Validation (CSV) and Qualification & Validation (QV) strategies, plans, protocols, and reports for new and existing facilities, utilities, equipment, and computerized systems
  • Work with teams from Engineering, Manufacturing, IT, and Quality to ensure compliance and timely project delivery
  • Take part in audits and inspections related to CSV and QV, making sure documentation is complete and ready
  • Promote a culture of quality, compliance, and ongoing improvement in CSV and QV activities, guiding team members and partners
  • Support changes and corrections for CSV and QV processes
  • Act as the subject matter expert for regulations and guidelines, including EU GMP (EudraLex Volume 4, Annex 11 and 15) and FDA 21 CFR Part 11

Was du mitbringst

  • University degree in engineering, life sciences, computer science, or a related field
  • At least 5 years of experience in CSV and ideally QV within pharmaceuticals, biotechnology, or a regulated industry; QA experience is a plus
  • Proven ability to lead and coordinate complex validation projects with different teams
  • Strong knowledge of cGMP, GAMP, FDA, EMA, and other relevant rules and guidelines
  • Excellent technical writing, problem-solving, and project management skills
  • Fluent in written and spoken English; German is a plus, along with strong communication and people skills

Was wir dir bieten

  • Be part of an international company with advanced technology and a dedicated team
  • Work in a lively and flexible environment that helps you grow personally and professionally
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Über uns

Bavarian Nordic is a global vaccine company focused on improving health and saving lives through innovative vaccines. We are a trusted supplier of mpox and smallpox vaccines for public health and offer a strong portfolio of travel vaccines. Our headquarters are in Denmark, with offices for manufacturing, research, and sales across Europe and North America.

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