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CSV Validation Engineer

  1. Belgium, Antwerp
Geel
  1. Contract
Competitive
  1. Life Sciences, Commissioning, Qualification and Validation
38320
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CSV Validation Engineer - Geel, Belgium - 2 Months Initial Contract 

Are you local to Geel, and looking for your next contract role? We are recruiting for a CSV Validation Engineer, on behalf of our client, an innovative global biopharmaceutical company, supporting their mission to transform medicine and provide life-changing treatment. With an exciting new project in the pipeline, the successful candidate will be involved from design to handover and a contract extension is likely. The role is remote based, with occasional visits to their state-of-the-art facility required.

If you would like to help contribute towards solutions across various fields including human vaccines, rare diseases, oncology, and many more, this CSV Validation Engineer opportunity might the next role for you!

What you’ll do:
  • Develop, implement, and execute validation lifecycle documents (URS, DQ, IQ, OQ, PQ, TM, RV).
  • Perform hands-on validation of cGMP-critical computerised systems to meet user and regulatory requirements.
  • Generate and manage validation protocols and reports; support execution.
  • Ensure validated status of systems aligns with cGMP, cGLP, and company procedures.
  • Manage projects per  regulatory standards.
  • Stay current with FDA/EU validation requirements and provide technical guidance.
  • Assess change impacts on validation status and documentation.
  • Investigate and resolve validation-related issues.
What you’ll need:
  • Requires extensive experience working in a pharmaceutical sector and GMP environment
  • Strong communication skills
  • Capable of working independently and learns fast
  • Able to execute project to plan
  • Competent knowledge of Computer Systems Validation
  • Full understanding of relevant quality and compliance regulations
  • Capable of troubleshooting validation issues
  • Good knowledge English and Dutch
If this role is of interest to you, please apply now!
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