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CSV Engineer

  1. Antwerp
Antwerpen
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
29745

This vacancy has now expired

CSV Engineer – Contract – Biopharmaceuticals – Antwerp 

Our global biopharmaceutical client are looking for a Dutch-speaking CSV engineer to work at their state-of-the-art facility near Antwerp, Belgium. They are looking for someone with strong pharmaceutical industry project experience to work on rolling out software packages, and with good knowledge of validation.

If you have data migration experience with the ability to carry out related activities and tests, we would like to hear from you! As part of this CSV Engineer role, you will be tasked with conducting training with the team.

 The role will include:
  • Project management: researching, ensuring that everything is delivered on time
  • Validation tests
  • Data migration
  • Writing and adjusting procedures
  • Training
CSV Engineer 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 computerised systems to demonstrate compliance to cGMP, User, and Regulatory requirements.
  • Perform validation of systems.
  • Ensure that the Validated Status of computerised systems follows cGMP at all times.
  • Ensure projects are managed in conjunction with all required organisation and cGMP regulatory standards.
  • Keep current on emerging validation regulations and validation testing practices in order to meet or exceed cGMP requirements. Provide technical assistance on current US FDA and EU validation requirements.
  • Generate validation documentation (protocols/reports) and assist with the execution of protocols for computerised systems.
About you:
  • 5 years’ + experience working in a pharmaceutical sector and GMP environment
  • Good knowledge of English and Dutch language
  • Strong communication skills
  • Competent knowledge of Computer System Validation
  • Knowledge of validation publications
  • Full understanding of relevant quality and compliance regulations
  • Capable of troubleshooting validation issues associated with projects, process development
Does this sound like a good fit for you? Get in touch with us today to apply!

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

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