[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"project-ingenieur-mwd-qualifizierung-und-validierung":3,"similar-ingenieur-mwd-qualifizierung-und-validierung":39},{"id":4,"slug":5,"title":6,"skills":7,"budget":23,"duration":23,"location":24,"onsitePercent":25,"contractType":26,"foundAt":27,"category":28,"description":32,"rawText":33,"webTitle":34,"webText":35,"language":36,"projectId":37,"sourceUrl":38},5471,"ingenieur-mwd-qualifizierung-und-validierung","Ingenieur (m\u002Fw\u002Fd) Qualifizierung und Validierung",[8,9,10,11,12,13,14,15,16,17,18,19,20,21,22],"Pharmatechnik","Biotechnologie","Bio-Verfahrenstechnik","GMP","Validierung","Qualifizierung","Windchill","SAP","FMEA","IQ","OQ","Testspezifikation","Analyse","Dokumentation","FAT",null,"Mannheim",100,"contracting","2026-05-22T13:27:31+00:00",{"id":29,"slug":30,"label":31},14,"medical_tech","Medizintechnik","Qualifizierung und Validierung von verschiedenen Anlagen in der Pharmatechnik. Erstellung von Validierungsdokumenten gemäß GMP und Review von Designdokumenten. Beurteilung von Abweichungen und technischen Änderungen.","Ingenieur (m\u002Fw\u002Fd) Qualifizierung und Validierung\nProjektnummer: FE42-34236-MA\nStandort: Mannheim, Baden-Württemberg\nArbeitsweise: Vor Ort\nLaufzeit: Keine Angabe\nStartdatum: Keine Angabe\n\nDas sind deine Aufgaben in unserem Team:\n- Qualifizierung und Validierung von verschiedenen Anlagen\n\n- Erstellung von Validierungsdokumenten gemäß GMP (SRA, Validierungsplan, Testspezifikation {IQ, OQ}, Validierungsreport, Trace Matrix)\n\n- Einstellung von Validierungsdokumenten in Windchill\n\n- Review von Designdokumenten wie LH, PH, TD (technisches Design) und Testnachweisen\n\n- Review und Teilnahme an Meetings für die Risikobetrachtung\n\n- Beurteilung von Abweichungen, um ggf. Maßnahmen einzuleiten \n\n- Analyse von IBN und FAT Dokumenten\n\n- Beurteilung der Auswirkungen von technischen Änderungen oder Changes\n\nDas bringst du mit:\n- Erfolgreich abgeschlossenes Studium im Bereich Pharmatechnik, Biotechnologie, Bio-Verfahrenstechnik oder vergleichbaren Studiengängen\n\n- Fundierte Berufserfahrung im genannten Umfeld\n\n- Kenntnisse über allgemeine GMP-Vorgaben und der dazugehörigen Dokumentation\n\n- Erfahrung mit Windchill oder anderen Verwaltungssystemen wie z. B. SAP\n\n- Kenntnisse über Relevanz der Punkte in der FMEA\n\n- Selbstständige, teamorientierte Arbeitsweise\n\n- Verhandlungssichere Deutschkenntnisse sowie sehr gute Englischkenntnisse\n\nSkills: Analyse, Anlagen, Arbeitsweise, Biotechnologie, Design, Dokumentation, FAT, FMEA, GMP, IQ, OQ, Pharmatechnik, Qualifizierung, SAP, Testspezifikation, Validierung, Verfahrenstechnik, Windchill\n\nAnsprechpartner:\nJulia Gaschott\nTalent Sourcer\nFERCHAU GmbH, Niederlassung Mannheim\nLandteilstraße 33\n68163 Mannheim\n+49 621 40164-166\njulia.gaschott@ferchau.com","Ingenieur Qualifizierung und Validierung","Wir suchen einen erfahrenen Ingenieur für Qualifizierung und Validierung im pharmazeutischen Umfeld. In dieser Position übernehmen Sie die fachliche Verantwortung für die Qualifizierung und Validierung verschiedener Anlagen nach GMP-Standards. Zu Ihren Hauptaufgaben gehört die Erstellung umfassender Validierungsdokumente wie Validierungspläne, Testspezifikationen für IQ und OQ, Validierungsreports sowie Trace Matrix. Sie arbeiten mit modernen Dokumentenmanagementsystemen und führen Reviews von Designdokumenten durch. Die Teilnahme an Risikobetrachtungen und die Beurteilung von Abweichungen zur Einleitung entsprechender Maßnahmen gehören ebenso zu Ihrem Verantwortungsbereich wie die Analyse von IBN- und FAT-Dokumenten. Sie bewerten die Auswirkungen technischer Änderungen und Changes auf bestehende Systeme. Wir erwarten ein erfolgreich abgeschlossenes Studium in Pharmatechnik, Biotechnologie, Bio-Verfahrenstechnik oder einem vergleichbaren Studiengang sowie fundierte Berufserfahrung in diesem Bereich. Kenntnisse der GMP-Vorgaben und entsprechender Dokumentation sind essentiell. Erfahrungen mit Verwaltungssystemen wie Windchill oder SAP sowie Kenntnisse über FMEA-Relevanz runden Ihr Profil ab. Sie arbeiten selbstständig und teamorientiert und verfügen über verhandlungssichere Deutsch- sowie sehr gute Englischkenntnisse. Die Position bietet Ihnen die Möglichkeit, in einem innovativen Umfeld an zukunftsweisenden Projekten mitzuwirken und Ihre Expertise in der pharmazeutischen Validierung einzusetzen.","de","FE42-34236-MA","https:\u002F\u002Ftouch.ferchau.com\u002Fde\u002Fde\u002Fprojekt\u002F403477",{"items":40},[41,55,69,84,99,114,129,141,152,166,177,199,214,233,251],{"id":42,"slug":43,"title":44,"skills":45,"budget":23,"duration":23,"location":52,"onsitePercent":25,"contractType":26,"foundAt":53,"category":54},5511,"hardwareentwickler-produktbetreuung-medizintechnik-mwd","Hardwareentwickler Produktbetreuung Medizintechnik (m\u002Fw\u002Fd)",[46,47,48,49,50,15,51,31,12,20],"Elektrotechnik","Hardware-Design","Messtechnik","Linux","Python","MS Office","Erlangen","2026-05-22T14:25:48+00:00",{"id":29,"slug":30,"label":31},{"id":56,"slug":57,"title":58,"skills":59,"budget":23,"duration":64,"location":65,"onsitePercent":66,"contractType":26,"foundAt":67,"category":68},5295,"freiberuflicher-konstrukteur-3d-zeichnungen","Freiberuflicher Konstrukteur - 3D Zeichnungen",[60,61,62,63,31],"SolidWorks","3D-Konstruktion","Maschinenbau","Konstruktionstechnik","Dezember \u002F Januar 2025","Baden-Württemberg",2,"2026-05-21T16:39:19+00:00",{"id":29,"slug":30,"label":31},{"id":70,"slug":71,"title":72,"skills":73,"budget":23,"duration":23,"location":79,"onsitePercent":80,"contractType":81,"foundAt":82,"category":83},5293,"quality-spezialist-mwd-fuer-die-medizintechnik","Quality Spezialist (m\u002Fw\u002Fd) für die Medizintechnik",[74,75,31,76,77,78],"ISO 13485","Qualitätssicherung","CAPA-Maßnahmen","Qualitätsmanagement","Audits","Karlsruhe",50,"permanent","2026-05-21T16:39:08+00:00",{"id":29,"slug":30,"label":31},{"id":85,"slug":86,"title":87,"skills":88,"budget":23,"duration":23,"location":95,"onsitePercent":96,"contractType":81,"foundAt":97,"category":98},5292,"senior-expert-validation-engineer-mwd","(Senior) Expert Validation Engineer (m\u002Fw\u002Fd)",[89,90,91,92,31,93,77,94],"Validation Engineering","Prozessentwicklung","ISO13485","Lean\u002FSix Sigma","Produktionsprozesse","Englisch","Nordrhein-Westfalen",80,"2026-05-21T16:39:01+00:00",{"id":29,"slug":30,"label":31},{"id":100,"slug":101,"title":102,"skills":103,"budget":110,"duration":23,"location":111,"onsitePercent":80,"contractType":81,"foundAt":112,"category":113},5291,"regulatory-affairs-manager-mwd","Regulatory Affairs Manager (m\u002Fw\u002Fd)",[104,105,74,106,31,107,108,109],"Regulatory Affairs","MDR","FDA","Risikomanagement","Change-Control","Compliance","80.000 EUR p.a.","Bayern","2026-05-21T16:38:54+00:00",{"id":29,"slug":30,"label":31},{"id":115,"slug":116,"title":117,"skills":118,"budget":126,"duration":23,"location":111,"onsitePercent":80,"contractType":81,"foundAt":127,"category":128},5290,"senior-quality-manager-rd","Senior Quality Manager (R&D)",[119,120,121,122,123,124,74,125,107],"Quality Management","Quality Assurance","Quality Control","MedTech - MDR","MedTech - ISO13485","ISO 14971","EU MDR","100.000 EUR p.a.","2026-05-21T16:38:50+00:00",{"id":29,"slug":30,"label":31},{"id":130,"slug":131,"title":132,"skills":133,"budget":138,"duration":23,"location":111,"onsitePercent":80,"contractType":81,"foundAt":139,"category":140},5289,"quality-manager-mwd","Quality-Manager (m\u002Fw\u002Fd)",[119,120,121,122,123,134,135,136,137,78],"Six-Sigma","LEAN","8D","Qualitätsmanagementsystem","90.000 EUR p.a.","2026-05-21T16:38:43+00:00",{"id":29,"slug":30,"label":31},{"id":142,"slug":143,"title":144,"skills":145,"budget":149,"duration":23,"location":65,"onsitePercent":80,"contractType":81,"foundAt":150,"category":151},5288,"head-of-quality-assurance-mwd","Head of Quality Assurance (m\u002Fw\u002Fd)",[120,119,122,123,146,74,147,77,148],"ISO 9001","Führungserfahrung","Medizinprodukte","110.000 EUR p.a.","2026-05-21T16:38:34+00:00",{"id":29,"slug":30,"label":31},{"id":153,"slug":154,"title":155,"skills":156,"budget":23,"duration":163,"location":65,"onsitePercent":80,"contractType":26,"foundAt":164,"category":165},5287,"freiberuflicher-firmware-entwickler","Freiberuflicher Firmware-Entwickler",[157,158,159,160,161,162,74,31],"Firmware-Entwicklung","C\u002FC++","Embedded Systems","Microcontroller-Programmierung","IEC 60601","IEC 62304","Anfang Januar","2026-05-21T16:38:30+00:00",{"id":29,"slug":30,"label":31},{"id":167,"slug":168,"title":169,"skills":170,"budget":23,"duration":23,"location":174,"onsitePercent":80,"contractType":26,"foundAt":175,"category":176},5201,"technischer-redakteur-konstruktion-solidworks-mwd","Technischer Redakteur Konstruktion \u002F SolidWorks (m\u002Fw\u002Fd)",[60,171,172,31,105,173,51,62],"3D-CAD","Technische Dokumentation","Konstruktion","Lübeck","2026-05-21T15:25:53+00:00",{"id":29,"slug":30,"label":31},{"id":178,"slug":179,"title":180,"skills":181,"budget":23,"duration":193,"location":194,"onsitePercent":195,"contractType":196,"foundAt":197,"category":198},5099,"ivd-product-lead-external-manufacturing","IVD Product Lead External Manufacturing",[182,74,183,184,185,186,187,188,189,190,191,192],"IVD product management","IVDR","FDA 21 CFR","Product specification","Production process specification","Leadership","German","English","Engineering","Natural Science","OPEX\u002FCAPEX","12++ months","Rotkreuz",90,"temp_work","2026-05-21T12:06:25+00:00",{"id":29,"slug":30,"label":31},{"id":200,"slug":201,"title":202,"skills":203,"budget":23,"duration":211,"location":23,"onsitePercent":80,"contractType":26,"foundAt":212,"category":213},5005,"cmc-regulatory-expert-mwd-fokus-peptid-parenterale-originalpraeparate-2","CMC Regulatory Expert (m\u002Fw\u002Fd) – Fokus Peptid \u002F parenterale Originalpräparate",[204,205,206,207,104,208,209,210],"CMC-Dokumentation","Originalpräparate","parenterale Peptid-Produkte","Modul 3 (Quality)","EMA\u002FFDA Anforderungen","Dossier-Erstellung","Manufacturing Change Control","bis mindestens 31.12.2026 (Option auf Verlängerung)","2026-05-21T08:16:18+00:00",{"id":29,"slug":30,"label":31},{"id":215,"slug":216,"title":217,"skills":218,"budget":23,"duration":229,"location":230,"onsitePercent":80,"contractType":26,"foundAt":231,"category":232},5004,"senior-analytical-scientist-hplcuhplc-biologics-2","Senior Analytical Scientist (HPLC\u002FUHPLC, Biologics)",[219,220,221,222,223,224,225,226,227,228],"HPLC","UHPLC","Chromatographie","Biologics","Proteinbiochemie","Methodenentwicklung","Thermo Fisher UHPLC-Systeme","Chromeleon Software","SEC","RP","ca. 9 Monate","Österreich","2026-05-21T08:16:11+00:00",{"id":29,"slug":30,"label":31},{"id":234,"slug":235,"title":236,"skills":237,"budget":23,"duration":23,"location":248,"onsitePercent":25,"contractType":26,"foundAt":249,"category":250},4585,"laborant-zellkultur-mwd","Laborant Zellkultur (m\u002Fw\u002Fd)",[238,239,240,241,11,242,243,244,245,246,247],"Anlagen","Auswertung","Entwicklung","Fermentation","Herstellung","Optimierung","Planung","Teamfähigkeit","Zellkultur","Zelllinien","Biberach an der Riß","2026-05-20T02:26:18+00:00",{"id":29,"slug":30,"label":31},{"id":252,"slug":253,"title":254,"skills":255,"budget":23,"duration":23,"location":248,"onsitePercent":25,"contractType":26,"foundAt":263,"category":264},4550,"technischer-assistent-hplc-analytik-mwd","Technischer Assistent HPLC-Analytik (m\u002Fw\u002Fd)",[219,11,256,257,21,258,259,260,261,262],"Analytik","Methodenvalidierung","Empower","LabWare-LIMS","MS-Office","Chemielaborant","Biologielaborant","2026-05-19T16:25:57+00:00",{"id":29,"slug":30,"label":31}]