{"id":7059132,"date":"2024-09-09T09:22:43","date_gmt":"2024-09-09T09:22:43","guid":{"rendered":"https:\/\/jeffersonwells.be\/vacancies\/24893-csv-engineer\/"},"modified":"2024-09-09T09:22:43","modified_gmt":"2024-09-09T09:22:43","slug":"24893-csv-engineer","status":"publish","type":"matador-job-listings","link":"https:\/\/jeffersonwells.be\/nl\/vacancies\/24893-csv-engineer\/","title":{"rendered":"CSV Engineer"},"content":{"rendered":" <ul class=\"matador-job-meta matador-job-meta-job-7059132 matador-job-meta-default\"> <li class=\"matador-job-meta-field matador-job-field-job_general_location matador-job-field-value-braine-lalleud\"> <span class=\"matador-job-meta-label\">Locatie:<\/span> <span class=\"matador-job-meta-value\">Braine-l&#039;Alleud<\/span> <\/li> <li class=\"matador-job-meta-field matador-job-field-bullhorn_job_id matador-job-field-value-24893\"> <span class=\"matador-job-meta-label\">Vacature<\/span> <span class=\"matador-job-meta-value\">#24893<\/span> <\/li> <\/ul> <p><span><span><strong><span>CSV Engineer<\/span><\/strong><\/span><\/span><br \/> <span><span><strong><span>Contracting \u2013 Braine L\u2019Alleud<\/span><\/strong><\/span><\/span><\/p> <p><span><span><strong><span>Les Responsabilit\u00e9s<\/span><\/strong><\/span><\/span><br \/> <span><span>&#8211; D\u00e9finir et assurer le suivi des strat\u00e9gies de qualification CSV qui touchent au projet OMP<\/span><\/span><br \/> <span><span>&#8211; Identifier l\u2019approche d\u2019impl\u00e9mentation de ces strat\u00e9gies (Change Control, autres)<\/span><\/span><br \/> <span><span>&#8211; D\u00e9terminer les impacts validation sur base des release notes du fournisseur<\/span><\/span><br \/> <span><span>&#8211; \u00c9valuer la compatibilit\u00e9 avec les logiciels \/ micrologiciels existants<\/span><\/span><br \/> <span><span>&#8211; Comprendre, appliquer et communiquer sur les pr\u00e9requis de validation<\/span><\/span><br \/> <span><span>&#8211; Identifier et contr\u00f4ler les risques inh\u00e9rents au projet<\/span><\/span><br \/> <span><span>&#8211; R\u00e9diger les documents de qualification conform\u00e9ment aux SOP<\/span><\/span><br \/> <span><span>&#8211; Planifier, organiser et coordonner les activit\u00e9s de validation, en lien avec l\u2019\u00e9quipe projet<\/span><\/span><br \/> <span><span>&#8211; Ex\u00e9cuter et\/ou v\u00e9rifier les tests de qualification des installations en impliquant les futurs utilisateurs et\/ou le fournisseur et conform\u00e9ment aux proc\u00e9dures en vigueur<\/span><\/span><br \/> <span><span>&#8211; Reporter \u00e0 sa hi\u00e9rarchie tout probl\u00e8me ayant un impact sur le planning d\u2019impl\u00e9mentation ou le d\u00e9roulement de la mission<\/span><\/span><br \/> <span><span>&#8211; Supporter ou prendre \u00e0 charge des activit\u00e9s li\u00e9es \u00e0 de l\u2019am\u00e9lioration continue<\/span><\/span><br \/> <span><span>&#8211; Assurer le respect de la l\u00e9gislation et des normes en vigueur ainsi que des r\u00e8gles de s\u00e9curit\u00e9 interne.<\/span><\/span><br \/> <span><span>Cette liste est non-exhaustive et sera amen\u00e9e \u00e0 \u00e9voluer en fonction de l\u2019avancement du projet. Par ailleurs, la personne pourra compl\u00e9ter des p\u00e9riodes plus calmes par la gestion des activit\u00e9s de qualification\/validation CSV li\u00e9s au projet automation en cours (autre que ceux d\u2019OMP), soit<\/span><\/span><br \/> <span><span>: o D\u00e9finir et assurer le suivi des strat\u00e9gies de qualification\/validation CSV.<\/span><\/span><br \/> <span><span>o Evaluer l\u2019impact qualification inh\u00e9rent au risques identifi\u00e9s.<\/span><\/span><br \/> <span><span>o R\u00e9diger les documents de qualification conform\u00e9ment aux SOP de qualification \/ validation.<\/span><\/span><br \/> <span><span>o Identifier l\u2019approche d\u2019impl\u00e9mentation de ces strat\u00e9gies (Change Control, autres).<\/span><\/span><br \/> <span><span>o Planifier, organiser et coordonner les activit\u00e9s de validation, en lien avec l\u2019\u00e9quipe projet.<\/span><\/span><br \/> <span><span>o Ex\u00e9cuter et\/ou v\u00e9rifier les tests de qualification \/ validation des installations en impliquant les futurs utilisateurs et conform\u00e9ment aux proc\u00e9dures en vigueur.<\/span><\/span><br \/> <span><span>o Reporter \u00e0 sa hi\u00e9rarchie tout probl\u00e8me ayant un impact sur le planning d\u2019impl\u00e9mentation des dits projets \u00e9ventuels.<\/span><\/span><br \/> <span><span>o Donner le support CSV aux activit\u00e9s du d\u00e9partement Site Process Validation (gestion de d\u00e9viations, CAPA, pr\u00e9paration et\/ou participation aux audits, \u2026).<\/span><\/span><br \/> <span><span>o Mettre \u00e0 profit son expertise CSV afin de r\u00e9pondre \u00e0 des sujets sp\u00e9cifiques (position papers, analyses de risque, \u2026) En fonction des priorit\u00e9s des projets et de l\u2019\u00e9volution de ceux-ci, la charge de travail pourra \u00e9voluer.<\/span><\/span><\/p> <p><span><span><strong><span>Expertise et Connaissances Requises <\/span><\/strong><\/span><\/span><br \/> <span><span>&#8211; Bachelor \/ Master de pr\u00e9f\u00e9rence \u00e0 orientation informatique\/automation industrielle et autrement, dans un domaine scientifique.<\/span><\/span><br \/> <span><span>&#8211; Au minimum 05 ans d\u2019exp\u00e9rience dans le domaine de la validation dont au moins 03 ans sur les syst\u00e8mes automatis\u00e9s et\/ou informatis\u00e9s et en particulier sur des mises \u00e0 jour \/ upgrade \/ revamping de software \/ firmware.<\/span><\/span><br \/> <span><span>&#8211; Compr\u00e9hension des flux, des pratiques, des m\u00e9thodologies et des d\u00e9livrables de validation.<\/span><\/span><br \/> <span><span>&#8211; Connaissance confirm\u00e9e de la partie automation des proc\u00e9d\u00e9s industriels pharmaceutiques (laveuses, testeurs de gants, RABS, isolateur, sertisseuse, remplisseuse, scelleuse, tunnel de d\u00e9pyro, autoclave, testeurs de filtres, stations CIP\/SIP, centrales d\u2019acquisition comprimeuse, m\u00e9langeur, syst\u00e8me d\u2019inspection visuel, syst\u00e8me de s\u00e9rialisation).<\/span><\/span><br \/> <span><span>&#8211; Connaissance confirm\u00e9e de la partie \u00e9quipements de laboratoire (RMN, \u00e9lectrophor\u00e8ses, spectro UV Vis, Spectro FTIR, qPCR, MALDI TOF etc.).<\/span><\/span><br \/> <span><span>&#8211; Connaissances des param\u00e8tres et \u00e9l\u00e9ments de conception pouvant avoir un impact qualit\u00e9 sur les proc\u00e9d\u00e9s susmentionn\u00e9s.<\/span><\/span><br \/> <span><span>&#8211; Connaissance des techniques en IT\/Computer System Validation. &#8211; Compr\u00e9hension et facilit\u00e9 d\u2019expression en anglais.<\/span><\/span><br \/> <span><span>&#8211; Capacit\u00e9 \u00e0 prendre des responsabilit\u00e9s et des d\u00e9cisions.<\/span><\/span><br \/> <span><span>&#8211; Capacit\u00e9 \u00e0 entretenir de bonnes relations avec les acteurs du projet.<\/span><\/span><br \/> <span><span>&#8211; Capacit\u00e9 de persuasion et comp\u00e9tence d\u2019assertivit\u00e9.<\/span><\/span><br \/> <span><span>&#8211; Rechercher et analyser les causes de d\u00e9faillances, et proposer des solutions innovantes pour y rem\u00e9dier.<\/span><\/span><br \/> <span><span>&#8211; Capacit\u00e9 \u00e0 \u00e9tablir des liens entre les concepts et \u00e0 faire preuve de recul (helicopter view).<\/span><\/span><br \/> <span><span>&#8211; Autonome et flexible.<\/span><\/span><br \/> <span><span>&#8211; Facult\u00e9 \u00e0 comprendre, \u00e0 suivre et \u00e0 faire siennes les d\u00e9cisions prises avec le line manager.<\/span><\/span><br \/> <span><span>&#8211; Esprit analytique et capacit\u00e9 de raisonnement logique marqu\u00e9e.<\/span><\/span><br \/> <span><span>&#8211; M\u00e9thodique, rigoureux, proactif et organis\u00e9.<\/span><\/span><br \/> <span><span>&#8211; Orient\u00e9(e) qualit\u00e9 et client (manager CSV).<\/span><\/span><br \/> <span><span>&#8211; Facilit\u00e9 \u00e0 travailler en \u00e9quipe et \u00e0 soutenir ses coll\u00e8gues, \u00e0 communiquer et \u00e0 parler d\u2019une seule et m\u00eame voix.<\/span><\/span><br \/> <span><span>&#8211; Franchise, \u00e9thique, honn\u00eatet\u00e9, respect &amp; int\u00e9grit\u00e9.<\/span><\/span><br \/> <span><span>&#8211; Capacit\u00e9 \u00e0 coordonner diff\u00e9rents projets en m\u00eame temps.<\/span><\/span><\/p> <p><span><span><strong><span>Notre Offre<\/span><\/strong><\/span><\/span><br \/> <span><span>Si vous \u00eates passionn\u00e9(e) par l&apos;innovation et que vous souhaitez contribuer \u00e0 un projet stimulant au sein d&apos;une entreprise de renomm\u00e9e mondiale, postulez d\u00e8s aujourd&apos;hui \u00e0 notre offre. Jefferson Wells s\u2019engage \u00e0 vous offrir un contrat en consultance, un accompagnement rapproch\u00e9 ainsi qu\u2019un salaire et un package attractifs. Des questions ? Vous souhaitez soumettre votre candidature ? Envoyez un mail \u00e0 aylin.ugurlu@jefferson.wells.be .<\/span><\/span><\/p> <nav class=\"matador-job-navigation\"> <ul> <li> <a href=\"https:\/\/jeffersonwells.be\/nl\/vacancies\/24893-csv-engineer\/\" rel=\"button\" class=\"matador-button\" title=\"Solliciteren Direct\">Solliciteren Direct<\/a> <\/li> <\/ul> <\/nav> ","protected":false},"excerpt":{"rendered":"<p>Locatie: Braine-l&#039;Alleud Vacature #24893 CSV Engineer Contracting \u2013 Braine L\u2019Alleud Les Responsabilit\u00e9s &#8211; D\u00e9finir et assurer le suivi des strat\u00e9gies de qualification CSV qui touchent au projet OMP &#8211; Identifier l\u2019approche d\u2019impl\u00e9mentation de ces strat\u00e9gies (Change Control, autres) &#8211; D\u00e9terminer les impacts validation sur base des release notes du fournisseur &#8211; \u00c9valuer la compatibilit\u00e9 avec &hellip; <a href=\"https:\/\/jeffersonwells.be\/nl\/vacancies\/24893-csv-engineer\/\" class=\"more-link\">Lees verder <span class=\"screen-reader-text\">&#8220;CSV Engineer&#8221;<\/span><\/a><\/p>\n","protected":false},"template":"","meta":{"_matador_source_id":"24893"},"matador-categories":[1420592],"matador-locations":[1420020],"matador-types":[1419976],"matador-provinces":[1420489],"class_list":["post-7059132","matador-job-listings","type-matador-job-listings","status-publish","hentry","matador-categories-life-sciences","matador-locations-braine-lalleud","matador-types-contracting","matador-provinces-walloon-brabant"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>CSV Engineer - Jefferson Wells<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/jeffersonwells.be\/vacancies\/24893-csv-engineer\/\" \/>\n<meta property=\"og:locale\" content=\"nl_NL\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CSV Engineer - Jefferson Wells\" \/>\n<meta property=\"og:description\" content=\"Locatie: Braine-l&#039;Alleud Vacature #24893 CSV Engineer Contracting \u2013 Braine L\u2019Alleud Les Responsabilit\u00e9s &#8211; 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