About this role
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 You are structured, quality-minded and eager to learn. You communicate effectively with different stakeholders and enjoy working in a team-oriented GMP environment. At the same time, you are capable of independently managing documentation and qualification activities. What you bring Bachelor's or Master's degree in a scientific or technical field such as Industrial Engineering, Biochemistry, Biotechnology or Pharmaceutical Sciences Strong interest in the pharmaceutical industry and GMP-regulated environments Excellent technical writing and documentation skills Experience with engineering systems, utilities or manufacturing equipment is an asset Fluent in Dutch and English , both written and spoken