Commissioning & Qualification Equipment Engineer | Pharma | Beerse
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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