As a Qualification & Validation Engineer you will be responsible for runing the qualification test, creating, updating and maintaining validation protocols and reports, compiling and analyzing data against established acceptance criteria.
• As a Validation engineer, you will perform qualification & validation activities related to your part of the business: bulk, finishing, packing
• You will help define and support the Validation Approach,
• You will establish procedures for Validation in accordance with international standards (FDA, EMA, ICH, ASTM E2500, GAMP),
• You will write Validation documents (protocols, reports, SOPs, Critical Impact Assessments, …)
• You will manage deviations,
• You will coordinate and execute validation (IQ, OQ, PQ) tests,
• You will perform risk assessments,
• You will work in close collaboration with production, engineering, maintenance, QC, QA…
• You will ensure handover with final users.
• Master in Engineering, Biology, Biochemistry, Chemistry, Pharmacy, or equivalent based on professional experience
• First experience as Validation 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 firstname.lastname@example.org