4 days ago

Computer System Validation (CSV) Engineer


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Axians in Switzerland is an agile company network of VINCI Energies Schweiz close to our customers with decisions, strategy and presence. We work with Best Practices of the market to provide our customers with prime quality ICT Services and customized solutions.

Computer System Validation (CSV) Engineer

For one of our customers, an international Life Science enterprise, we are looking for an experienced CSV Engineer.

Your Responsibilities:

  • Lead validation activities of Computerized Systems in the Life Sciences Industry
  • Assist in maintaining equipment automation systems in a validated state as they relate to GxP CSV automation systems
  • Execute QA reviews of IT SOPs and create Validation Master Plans for computerized system implementations
  • Develop appropriate documentation and ensure all documents filings and archiving systems are accurate, up to date and maintained in accordance with GMP and other relevant regulations
  • Establish and ensure good and close working relationship with important project stakeholders and internal customers

Your Qualifications:

  • University degree in Engineering, IT, Science or Computer related discipline
  • 5 years proven track record in Computer System Validation in Pharmaceutical or Life Science environment
  • Strong project management skills in the CSV area with the ability to prioritize assignments
  • Familiar with GxP
  • Very good knowledge of GAMP 5, Annex 11, CFR Part 11 Compliance and CFR Part 210, 211 & 820 compliance
  • Excellent analytical and problem-solving skills
  • Able to cope with complexity, autonomous and pro-active
  • Willing to work in an international environment
  • Fluent in English and German, very good French knowledge is an advantage
  • Willingness to travel within Switzerland

We can offer you:

  • An international and highly dynamic environment
  • Benefits of a permanent employment incl. development opportunities
  • Fringe Benefits

Are you interested? Then we are looking forward to your application.

Axians redtoo AG
Erika Brazenaite
Operations Manager Skills & Services
Nenzlingerweg 2
4153 Reinach