Validation Engineer
Vlaams Gewest, Belgium
About the role
For an international player in the cosmetics industry, we are looking for a Validation Engineer. In this role, you support the qualification of laboratory equipment and the validation of software systems in a GMP-regulated environment. You ensure that equipment, software, data, and controls meet established quality and compliance requirements and are fit for their intended use. Your responsibilities • Establish, plan, and execute qualification activities for laboratory equipment, including risk analyses, DQ, IQ, OQ, and PQ. • Develop protocols, test scenarios, and reports, and ensure correct documentation of all activities. • Review vendor documentation and support installation, commissioning, calibration checks, acceptance testing, and equipment release. • Apply a risk-based approach for Computer Software Assurance (CSA) of laboratory software. • Evaluate functions and controls such as user management, audit trails, electronic signatures, interfaces, calculations, data migration, and backup procedures. • Support changes, deviations, CAPA processes, periodic reviews, requalifications, upgrades, and system decommissioning. • Establish, manage, and update validation and qualification documentation in accordance with GMP, GDP, and internal procedures. • Collaborate with various stakeholders and report progress, risks, and points of attention in a timely manner. • Bachelor's or Master's degree in a scientific, technical, or IT-related field, or equivalent through experience. • Knowledge of GMP, GDP, data integrity, risk management, equipment qualification, and computer software assurance. • Familiar with guidelines such as EU GMP Annex 11, 21 CFR Part 11, and GAMP 5. • Experience in a pharmaceutical, chemical, food, or other regulated production environment is a plus. • Experience with validation protocols, testing, deviations, change controls, and document review is an asset. • Good knowledge of Dutch and English. Remuneration: to be negotiated.