Qualification Engineer - Life Sciences (Flanders) > Joboolo BE :
Company : Akkodis Location : From : Talent BE
Installation Qualification (IQ) The documented verification that all aspects of a facility, utility or equipment that can affect product quality adhere to approved specifications (., construction, materials) and are correctly installed.Operational Qualification (OQ) The documented verification that all aspects of a facility, utility or equipment that can affect product quality operate as intended throughout all anticipated ranges.Performance Qualification (PQ) The documented verification that all aspects of a facility, utility or equipment that can affect product quality perform as intended meeting predetermined acceptance criteria.of all manufacturing equipment (sterile & non-sterile)The Commissioning & QualificationEngineer:
Is responsible to maintain the qualification status of systems in support of new, transferred and existing products through definition & maintenance of contemporary methodologies & standards.Supports the Commissioning & QualificationEngineering Department in providing documented evidence that all equipment and utilities used are qualified and remain in a state of control so that they deliver processes and products that comply to regulatory and business specifications.Is responsible for review of System Qualification documents.Is responsible for writing and executing qualification protocols, tests and –reports based on user, quality, technical and functional requirements and other relevant information as delivered by the project team.
If required, he/she will also assist the project team in writing these (project) documents.Act as Technical OwnerSteers under minimal guidance specialists and contractors within own discipline and/or responsibility areaParticipates in the development of global standards/guidelines, reviews local standards/guidelinesPrepares for internal and external inspections and acts the spokesperson and Subject Matter Expert during audits and inspections, as pertainsQualificationEngineering topics.Based on expertise, makes strong recommendations on investigations, investments or projectsABOUT USThe Akkodis Group is an international engineering consulting and R&D services company.
As an innovation accelerator for its clients, Akkodis supports leading industry players in the automotive, aerospace, rail, space, defense, energy and lifesciences sectors throughout the life cycle of their products with cutting edge digital technologiesWith more than 55.000 experts in over 30 countries, Akkodis is one of the leaders in its field.
In Belgium, we have close to 1000 experts active in different technical fields.
Business IndustryLifesciences Profile YOU PROFILEWork experience in pharmaceutical industry, preferred3 + year of experience in commissioning & qualification of pharmaceutical manufacturing equipmentUniversity Master Degree in (Bio-)Engineering or ScienceStrong technical skills and interest (electrical and mechanical)Knowledge of GMP requirements, methodologies, concepts and requirements related to system validationQuick learner and good eye for detailsExcellent communication and coordination skillsAbility to work under pressure, flexibility and positive attitude to challenges would be added advantage.Ability to take decisionsAbility to work independently under general directionFluency in written and spoken EnglishOUR OFFERAs an Akkodis consultant, you will be:
In charge of diverse transversal and empowering projectsSupported in your career by your Akkodis ManagerActor of your training plan and your personal and professional developmentMember of a dynamic and collaborative community of engineersBenefiting from a permanent contractBenefiting from a competitive salary packages including several extra-legal benefits.Position location Job locationEurope, Belgium, Brussels Region, Brussels Location BelgiumCandidate criteria Level of experienceAll levels of experience LanguagesEnglish (3 :
