As a Commissioning and Qualification Expert, you are responsible for the startup of the plant. You have to guarantee the installation functions according to contractual requirements and is ready for final delivery to the client.
• You will manage commissioning at different phases (start-up , qualification…) in compliance with contracts conditions and clients requirements,
• You will define the Qualification Approach,
• You will establish procedures for qualification in accordance with international standards (FDA, EMA, ICH, ASTM E2500, GAMP),
• You will write qualification documents,
• You will perform FAT/SAT and Equipment Commissioning,
• You will coordinate and execute qualification (IQ, OQ) tests,
• You will work in close collaboration with production, EHS, engineering, maintenance, QC, QA…
• You will ensure handover with final users.
• Master in bio-engineering or similar
• At least 5 years experience in C&Q in a GMP environment
• Good interpersonal and communication skills
• Flexible, solutions oriented, proactive, having an excellent critical and analytical mind and being stress resistant
• Fluent in French or Dutch and in English,
• Excellent knowledge of MS Office
• Flat hierarchie, empowering each individual is the organization's DNA
• Transparent intrapreneurship model, with immediate and long term rewards for each collaborator
• Human centric, we respect value and foster each individual's skills, elevating us all together
• High potential for both personal and professional development
• Tailored training path
• Attractive salary package
With a solid background in innovation and R&D, Ellion is supporting the Belgian Life Sciences market in all their manufacturing & development projects.
Ellion has been founded by two friends combining more than 20 years experience in consulting and a single idea in mind : building the consulting company they would have loved to work for!
At Ellion, we disrupt the consulting standards by putting our members at the heart of the organization. There are no intermediate levels of management here. We respect, value and foster each individual's skills, elevating us all together. Tailored career plan and people empowerment are the organization's DNA.
An innovative and transparent reward system ensures direct and long term benefits for each collaborator participating in our intrapreneurship vision.
What if your job was to achieve interesting and challenging projects with a team that feels more like a group of supporting friends than strangers with opposite interests? That’s how we want you to experience every day at work!
You just found your Nest, join us!
Send your CV at email@example.com