Added: 2025-04-15 13:36.00
Updated: 2025-04-22 03:08.12

Qualification Engineer

Nivelles , Wallonia, Belgium

Type: n/a

Category: Engineering & Manufacturing

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Requirements: English
Company: MindCapture
Region: Nivelles , Wallonia

Your mission: As a qualification & validation consultant , youll take a lead role in qualifying and validating equipment, systems and processes that are central to biotech and pharmaceutical projects. This role is perfect for a detail-oriented, tech-savvy professional who loves making sure every component works seamlessly and meets the highest standards. What Youll Do: Equipment & System Qualification Commission & validate : Whether its new equipment or existing systems, youll ensure everything is qualified, validated, and ready to perform. Installation qualification (IQ) : Verify that equipment is installed precisely according to design specsno detail is too small! Operational qualification (OQ) : Put systems through their paces to confirm they operate within all specified limits. Performance qualification (PQ) : Test for consistent, reliable performance under typical operating conditions, so we know systems are ready for action. Process Validation (PV): Demonstrate that the manufacturing process consistently produces products that meet quality standards, ensuring it performs reliably and remains in a state of control over time. Master of documentation Qualification & validation protocols : Youll develop and execute protocols that capture every detail of the qualification and validation processes. SOPs & records : Create and manage standard operating procedures, calibration logs, and maintenance records to keep everything compliant and organized. Compliance & calibration : Ensure all equipment is calibrated and maintained to meet ISO, GMP, and other regulatory standards. Change control records : Manage change control documentation to track and document any updates or modifications in the system. Champion of continuous improvement Your top skills: Background : You hold a masters degree in a scientific or engineering field (e.g., bio-engineering, bioinformatics, industrial engineering, civil engineering, etc.). Validation Expertise: you have a first experience in equipment and/or system validation within life sciences or biotech. Youre not scared of some documentation: creating SOPs, validation plans, calibration records, and other technical documentation: youre up for it. Analytical & problem-solver: youre someone who digs deep to analyze processes and equipment, identifying quality gaps and implementing practical solutions. You are detail-oriented , eager to learn, and adaptable to new challenges. Team player & communicator: You can work easily across teams, from quality control to engineering, making sure every project stage aligns with the highest standards.
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