Validation Engineer

Il y a 4 jours

Brussel Hoofdstad, Belgique ELMEA Consulting Group Temps plein 55 000 € - 75 000 €/an
  • Plan, execute, and review qualification protocols (IQ, OQ, PQ) for equipment, utilities, and facilities
  • Perform Computer System Validation (CSV) activities in line with GAMP 5 guidelines
  • Author and review validation documentation: VMP, URS, FS, DS, test protocols, and final reports
  • Collaborate with cross-functional teams including QA, IT, production, and engineering
  • Manage deviations and CAPAs related to validation activities
  • Support regulatory inspections and internal audits from a validation perspective
  • Ensure compliance with applicable regulations (FDA 21 CFR Part 11, Annex 11, EU GMP)

Required profile.

  • Engineering or science degree (biomedical, chemical, pharmaceutical, or equivalent)
  • Minimum 3 years of experience in validation within a GMP-regulated environment
  • Strong knowledge of GAMP 5, FDA 21 CFR Part 11, and EU Annex 11
  • Experience with CSV and/or process validation is a strong asset
  • Rigorous, structured, and detail-oriented approach to documentation
  • Fluent in English; French and/or Dutch is a plus

We are always on the lookout for talented people to enrich our culture and growing family.