Validation Specialist (CSV)

Posted 08 November 2021
SalaryNegotiable
LocationBern
Job type Limited
DisciplineLife SciencesIT/Software Development
ReferenceBBBH493060_1636385514

Job description

For our client a Global Pharmaceutical Company in Bern, we are currently looking for a new team member as


Validation Specialist (CSV)

Main Responsibilities

  • Coordination of computerized system qualification and validation activities within the Quality Control department
  • Define the validation strategy
  • Perform and/or support the writing of specification documents (URS)
  • Review test protocols, plans and reports
  • Support test execution
  • Support and train team members in CSV methodology
  • Supporting the timely and effective completion of investigations, change controls and CAPA's

Who we are looking for

  • Degree in a LifeSciences/ Biotechnology, Chemistry discipline or comparable work experience
  • Several years of experience in computerized system validation (CSV) in a GMP environment and good knowledge of related regulatory requirements in the life sciences industry (GAMP 5, 21 CFR part 11, ...)
  • Good understanding of analytical technologies,
  • Strong analytical thinking and problem-solving ability
  • Excellent communication and teamwork skills
  • Ability to simultaneously support multiple projects, duties and assignments and prioritize accordingly
  • Excellent writing skills for scientifically sound technical documents, instructions, protocols and reports.
  • Self-dependent way of working and taking ownership of assigned task to plan and deliver according to agreed timelines.
  • Good verbal and written skills in English, German is a plus


Workplace: Bern
Workload: 100%
Working Time: flexible working hours
Start Date: 01.01.2022
Duration: 12 months

Your Application
Please apply online. For further information about the position, please contact your Kelly recruiter, Mr Franck Maerky (+41 61 270 80 17).