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AntwerpHybridHours negotiable<3months
A Validation Engineer is sought for a highly regulated production environment. You will contribute to the qualification of laboratory equipment and the validation of associated software applications. The goal is to ensure that installations, systems, and data remain reliable, compliant, and fit for use throughout their entire lifecycle.
What you will do.
- Prepare and execute qualification trajectories for laboratory equipment
- Draft and review URS, risk analyses, DQ, IQ, OQ
- Develop test protocols, perform tests, and process the results into clear reports
- Review technical documentation from suppliers
- Support installation, commissioning, calibration controls, acceptance tests
- Apply a risk-based approach for Computer Software Assurance
- Evaluate, among other things:
- User rights and access management
- Audit trails
- Electronic data and signatures
- Interfaces and automated calculations
- Data migration
- Backup and recovery processes
- Support changes, deviations, CAPAs, periodic reviews, upgrades
- Draft and manage correct, traceable, and audit-ready validation documentation
- Coordinate with colleagues from quality, engineering, IT, automation
- Follow up on planning, risks, and open actions
What they ask
- Bachelor's or Master's degree in sciences, engineering, laboratory technology, IT
- First relevant experience in validation, qualification, quality, laboratory operations, IT
- Knowledge of a regulated production environment and concepts such as:
- GMP and GDP
- Data Integrity
- Equipment Qualification
- Computer Software Assurance
- GAMP 5
- Experience with test protocols, deviations, changes, and evaluating test results is a plus
- Good communication skills in Dutch and English
Profile
- You work analytically, accurately
- You take responsibility for your files and escalate in a timely manner when necessary
Practical
- Long-term assignment within a production environment
- Technical scope with a focus on laboratory qualification and Computer Software Assurance
- Collaboration with various departments, including Quality, Engineering, IT
- Opportunity to take on responsibility independently and grow further within validation and qualification
How to apply
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