Commissioning & Qualification Equipment Engineer | Pharma | Beerse

Il y a 3 jours

Beerse, Antwerpen, Belgique SELECT PROJECTS (Select) Temps plein 65 000 € - 90 000 €/an

As a Commissioning & Qualification Equipment Engineer, you are responsible for preparing, maintaining and executing qualification documentation for GMP-critical equipment, utilities and systems. You ensure that all documentation complies with applicable GMP requirements and internal quality standards. You work closely with C&Q Leads, Subject Matter Experts and project teams to support qualification projects from initiation through completion. Besides document preparation, you also participate in qualification testing and follow-up activities. Your work plays an important role in ensuring that systems remain in a validated and compliant state. Fortunately, we can count on you for:

  • Writing qualification documentation including URS, SRS, IA, DQ, IQ, OQ, PQ, QSR and Validation Master Plans
  • Executing and documenting qualification tests for equipment, utilities and systems
  • Assessing the impact of changes, deviations and discrepancies on qualification activities
  • Coordinating document reviews, approval flows and signature processes
  • Following up punch list items and qualification actions until closure
  • Supporting internal and external audits and inspections
  • Managing document archiving in accordance with GMP and GDP requirements