At Capgemini Engineering we value excellence, care, responsibility, dynamism and innovation. We offer a job with variation that leaves plenty of room for initiative and development. In fact, we are not just offering you a job, we're inviting you to be part of our community where we will provide you trainings, tools & grounds for professional and personal growth. Each career experience is assorted by an attractive salary package.
If you are a team player, if you recognize yourself in this profile and are not afraid of taking on challenges… Apply today!
As a Qualification Engineer your role consists of qualifying equipment from replacements to introductions of new equipment materials. You are active in multidisciplainary project teams, which results in a combination of autonomous tasks and teamwork engagements with colleagues of all sorts of departments. It is your mission to be and become a specialist in all Qualification activities.
* You create and execute Qualification protocols, and report on the progress being made.
* You make sure GMP standards are being implemented and make sure they are translated in Qualification activities.
* You follow-up on all activities concerning the protocols, document the results, quality incidents and deviations.
* You define the cause, effect and actions and make sure the preventive measures are documented and managed.
* You present and defend the approach of the Qualification actions towards internal stakeholders.
* You participate in Continuous Improvement projects.
* You write operational procedures.
* You are active in this role in the region of Antwerp (Puurs, Geel, Beerse) and have contact with numerous contacts in diverse department throughout the complete organization.
* You have a Master degree in a Technical domain or equal by experience.
* You are familiar with GMP/GDP and have relevant experience with Qualification activities (writing URS, DQ, IQ, OQ, PQ protocols and reports, with testing and documentation, risk analysis, experience with P&ID's, etc.)
* You have prior experience in a GMP environment, preferably Pharma, Biotech and/or Medical Devices.
* Knowledge about safety documentation for Change Control would be an extra.
* You write and speak fluent Dutch and English
* You have strong administrative skills, pragmatic, able to work both autonomously and in team, critical and focused on solutions.
Job Type: Full-time