Computerized System Validation (CSV) Engineer – German speaker

Details

  • Category: Pharmaceutical
  • Location: North East of Switzerland
  • Starting date: Jan 02, 2020
  • Domain of experience: CSV, Data integrity, GMP, IT system
  • Level required: Intermediate
  • Years of experience: Minimum 5 years

Your Role

As CSV Engineer, you will be part of the Global Technology division for the Pharmaceutical Systems business unit. One of the main missions will be to validate computerized systems (IT systems) and to coordinate CSV activities in a global environment. Within the team, you will have a strong autonomy to manage your day-to-day missions.

Your Tasks

  • Plan and execute work packages and sub-projects independently for qualification / validation of computerized systems (project management, risk assessment, testing, documentation)
  • Carry out risk analyzes of IT systems according to specifications and standards (21CFR Part 11, EU-GMP Annex11, data integrity)
  • Create, review and update validation documents for computer systems (e.g. validation plan and report, specifications, risk analysis, test plans, software design specification, role and rights specification, etc.)
  • Coordinate and handle change requests for IT systems in the global environment
  • Interface communication to the IT department and global quality department
  • Support in local and global / cross-site projects including cost and scheduling

Your Profile

  • Master Degree or Bachelor in Computer Science or Life Sciences fields
  • Minimum 5 years of professional experience, including in computer system validation (CSV) for pharmaceutical industry
  • Very good knowledge of the relevant standards and laws (eg GMP, data integrity, GAMP, 21 CFR Part 11, EU-GMP Annex 11, etc.) and the requirements for the qualification and validation of computer systems
  • Independent, organized and ability to learn, enthusiasm and motivation
  • You have a good basic technical understanding and a strong IT affinity
  • Intercultural openness and the ability to communicate are a matter of course for you and working in a team is an asset to you
  • Very good oral and written communication skills in English and German are a must
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