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Computer Systems Validation (CSV) Engineer

  1. Antwerp
  1. Contract
Competitive
26008//AS
  1. Life Sciences, Commisions, Qualification and Validation
Date Posted06 Jan 2021
Our global bio-pharmaceutical client is seeking the expertise of a CSV Engineer - Computer Systems Validation - to support their state-of-the-art facility in Belgium. This role requires English and Dutch language skills. It will involve a combination of home-based and site-based work.

Responsibilities:
  • Development, implementation and execution of URS, SIA, DQ, IQ, OQ, PQ, RV and TM activities
  • Develop, implement and execute validation studies for cGMP-critical computerized systems to demonstrate compliance to cGMP, User, and Regulatory requirements
  • Perform validation of systems in accordance with cGMP and cGLP’s
  • Ensure that the Validated Status of computerized systems is in compliance with cGMP at all times
  • Provide technical assistance on current US FDA and EU validation requirements
  • Generate validation documentation (protocols/reports) and provide assistance with the execution of protocols for computerized systems
  • Responsible for the validation documentation through approval and implementation
  • Provide input in review/assessment of changes
  • Conduct statistical analysis of validation data & testing results
  • Investigate/troubleshoot validation problems
  • Develop protocols to ensure quality standards
  • Project experience with rolling out software packages 
  • Carry out Data migration activities and related tests - current procedures adapted and re-written
  • Towards the end of the project, carry out training of new application
 
Background:
  • Project management - able to execute projects to plan
  • Validation tests
  • Data migration
  • Writing and adjusting procedures
  • Delivering training
  • Competent knowledge of Computer Systems Validation
  • Full understanding of relevant quality and compliance regulations
  • Capable of troubleshooting validation issues associated with projects, e.g. process development
  • Pharmaceutical sector experience and GMP environment
  • Good knowledge of English and Dutch Language
  • Computerized systems / digital tools (e.g. BioLIMS Laboratory Execution System, Electronic flows)
  • Agile methodology knowledge

Please apply today for further information!

The candidate must have the rights to work in the location stated in the job advert.

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Our global bio-pharmaceutical client is seeking the expertise of a Validation Engineer to support their state-of-the-art facility in Belgium. This role requires English and Dutch languages. It will be

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