{"data":{"id":185683,"slug":"design-responsible","type":"job","title":"Design Responsible","description":"We are a growing company with approximately 1,000 employees in Sweden and over 40,000 employees worldwide. Our pride in our products permeates the entire company. In our employee surveys, colleagues, development opportunities, and a family-like atmosphere are highlighted as some of the best things about working at Fresenius Kabi.\r\n\r\nBeing part of Fresenius Kabi is synonymous with being part of an environment with future prospects. We believe in our employees and are passionate about developing all our staff members. You have great opportunities to influence how that development looks.\r\nFresenius Kabi has also, for the fourth year in a row, been designated as a Career Company and thus an attractive employer in Sweden thanks to our unique career opportunities.\r\nOur global organization means there is a great variety of paths to choose from as part of your future development.\r\n\r\n1 position(s).\r\n\r\n\nOperations Sweden is in an expansive phase where several products are being transferred to our site in Uppsala from Fresenius Kabi's R&D centers and factories in other parts of the world.\r\nDo you have a strong interest in product quality in Life Science and want to contribute to the development of life-saving medicines? Then this could be the right role for you.\r\n\r\nResponsibilities\r\nWe are looking for a Design Responsible with responsibility for finished products for the Tech Transfer & Product Lifecycle Management department. You are responsible for the regulatory documentation of products, product validation, and manufacturing methods and specifications. You also contribute to ensuring deliveries in our ongoing tech transfer projects. A large part of the position involves close collaboration with colleagues at Fresenius Kabi, nationally and internationally, where your contribution is crucial to the high quality of our products.\r\n\r\nParticipate in projects for new products and changes related to existing products\r\n\r\n\r\nResponsibility for product validation\r\n\r\n\r\nResponsibility for specifications and manufacturing methods\r\n\r\n\r\nIssue, review, and maintain registration documentation within Chemistry, Manufacturing and Controls (CMC)\r\n\r\n\r\nRespond to questions from authorities regarding the product during inspections and on submitted external documents\r\n\r\n\r\nAct as an expert in investigations of major deviations and changes\r\n\r\n\r\nResponsibility for stability studies and monitoring of relevant product trends\r\n\r\n\r\nCoordination to ensure that requirements in external documentation are followed internally\r\n\r\n\r\nAbout You\r\nWe are looking for someone who is self-driven, analytical, and structured. You should be quality-conscious and thorough in your work and be comfortable working in a rapidly developing operation. We see that you are highly communicative and collaborate well with internal and external contacts.\r\nWe are looking for someone who has:\r\n\r\nAcademic education in chemistry, pharmacy, or equivalent, such as a degree in chemical engineering or pharmacy\r\n\r\n\r\nAt least five years of experience from the pharmaceutical industry\r\n\r\n\r\nExperience with CMC documentation\r\n\r\n\r\nVery good ability to communicate in Swedish and English, both orally and in writing\r\n\r\n\r\nAbout the Position\r\nThe position is a fixed-term employment on probation which, after 6 months, will transition to permanent employment by agreement between the parties.\r\nStart date immediately.\r\n\r\nContact\r\nIf you would like to know more about the position, you are welcome to contact recruiting manager Johanna Lindh via e-mail johanna.lindh@fresenius-kabi.com.\r\nFor trade union contact persons, you can email unionen-klubben@fresenius-kabi.com to contact Unionen and akademikerforeningen@fresenius-kabi.com to contact Akademikerf\u00f6reningen.\r\nWe warmly welcome your application via the link. We unfortunately do not accept applications via e-mail or mail.\r\nSelection and interviews take place on an ongoing basis. The position may be filled before the final application deadline, so do not hesitate to submit your application today!\r\nOur recruitment process includes tests, interviews, reference checks, and background screening. At the interview, we ask you to present your degree certificate and relevant certificates. For the final candidate, a pre-employment health screening will be conducted by our occupational health service.\r\n\r\nEmployment Type: Permanent.\r\nDuration: Permanent.","language":"sv","is_translated":true,"title_original":"Design Responsible ","description_original":"Vi \u00e4r ett v\u00e4xande f\u00f6retag med cirka 1000 anst\u00e4llda i Sverige och \u00f6ver 40 000 anst\u00e4llda v\u00e4rlden \u00f6ver. V\u00e5r stolthet f\u00f6r v\u00e5ra produkter genomsyrar hela f\u00f6retaget. I v\u00e5ra medarbetarunders\u00f6kningar lyfts kollegorna, utvecklingsm\u00f6jligheterna och den familj\u00e4ra st\u00e4mningen upp som n\u00e5gra av de b\u00e4sta sakerna med att arbeta p\u00e5 Fresenius Kabi.\r\n\r\nAtt vara en del i Fresenius Kabi \u00e4r synonymt med att vara en del i en milj\u00f6 med framtidsutsikter. Vi tror p\u00e5 v\u00e5r personal och \u00e4r passionerad i v\u00e5r utveckling av alla v\u00e5ra medarbetare. Hur den utvecklingen ser ut har du stora m\u00f6jligheter att p\u00e5verka sj\u00e4lv.\r\nFresenius Kabi har dessutom, f\u00f6r fj\u00e4rde \u00e5ret i rad, blivit utsedda till Karri\u00e4rf\u00f6retag och d\u00e4rmed en attraktiv arbetsgivare i Sverige tack vare v\u00e5ra unika karri\u00e4rm\u00f6jligheter.\r\nV\u00e5r globala organisation medf\u00f6r att det finns en stor variation av v\u00e4gar att v\u00e4lja som ett led i din framtida utveckling.\r\n\r\n1 plats(er). \r\n\r\n\nOperations Sweden befinner sig i en expansiv fas d\u00e4r ett flertal produkter \u00e4r p\u00e5 g\u00e5ng att flyttas till v\u00e5r site i Uppsala, fr\u00e5n Fresenius-Kabis R&D-centers och fabriker i andra delar av v\u00e4rlden.\u00a0\u00a0\nHar du ett starkt intresse f\u00f6r produktkvalitet inom Life Science och vill bidra till utvecklingen av livsviktiga l\u00e4kemedel? D\u00e5 kan det h\u00e4r vara r\u00e4tt roll f\u00f6r dig.\u00a0\nArbetsuppgifter\nVi s\u00f6ker en Design Responsible (Konstruktionsansvarig) med ansvar f\u00f6r f\u00e4rdig produkt till avdelningen Tech Transfer & Product Lifecycle Management. Du ansvarar f\u00f6r produkternas regulatoriska dokumentation, produktvalidering samt tillverkningsmetoder och specifikationer. Du bidrar ocks\u00e5 till att s\u00e4kerst\u00e4lla leveranser i v\u00e5ra p\u00e5g\u00e5ende tech transfer-projekt. En stor del av tj\u00e4nsten inneb\u00e4r t\u00e4tt samarbete med kollegor inom Fresenius Kabi, nationellt och internationellt, d\u00e4r din insats \u00e4r avg\u00f6rande f\u00f6r v\u00e5ra produkters h\u00f6ga kvalitet.\u00a0\n\nMedverka i projekt f\u00f6r nya produkter och f\u00f6r\u00e4ndringar kopplat till befintliga produkter\u00a0\u00a0\n\n\nAnsvar f\u00f6r produktvalidering\u00a0\n\n\nAnsvar f\u00f6r specifikationer och tillverkningsmetoder\u00a0\n\n\nUtf\u00e4rda, granska och underh\u00e5lla registreringsdokumentation inom Chemistry,\u00a0Manufacturing\u00a0and Controls (CMC)\u00a0\n\n\nSvara p\u00e5 fr\u00e5gor fr\u00e5n myndigheter ang\u00e5ende produkt under inspektioner och p\u00e5 inskickade externa dokument\u00a0\n\n\nFungera som sakkunnig vid utredningar av st\u00f6rre avvikelser och \u00e4ndringar\u00a0\n\n\nAnsvar f\u00f6r stabilitetsstudier, samt bevakning av relevanta produkttrender\u00a0\n\n\nSamordning av att krav i extern dokumentation f\u00f6ljs internt\u00a0\n\n\nOm dig\r\n\nVi s\u00f6ker dig som \u00e4r sj\u00e4lvg\u00e5ende, analytisk och strukturerad.\u00a0Du ska vara kvalitetsmedveten och noggrann i ditt arbete samt vara bekv\u00e4m med att arbeta i en verksamhet under snabb utveckling. Vi ser att du \u00e4r mycket kommunikativ och samarbetar bra med interna och externa kontakter.\u00a0\u00a0\nVi s\u00f6ker dig som har:\u00a0\n\nAkademisk utbildning inom kemi, farmaci eller motsvarande, exempelvis civilingenj\u00f6rs- eller apotekarexamen\u00a0\u00a0\n\n\nMinst fem \u00e5rs erfarenhet fr\u00e5n l\u00e4kemedelsindustrin\u00a0\u00a0\n\n\nErfarenhet av\u00a0CMC-dokumentation\u00a0\u00a0\n\n\nMycket god f\u00f6rm\u00e5ga att kommunicera p\u00e5 svenska och engelska, i b\u00e5de tal och skrift\u00a0\n\n\nOm tj\u00e4nsten\r\nTj\u00e4nsten \u00e4r en visstidsanst\u00e4llning i pr\u00f6vosyfte som efter 6 m\u00e5nader \u00f6verg\u00e5r i tillsvidareanst\u00e4llning efter \u00f6verenskommelse mellan parterna.\r\nTilltr\u00e4de omg\u00e5ende.\nKontakt\r\nVill du veta mer om tj\u00e4nsten \u00e4r du v\u00e4lkommen att kontakta rekryterande chef Johanna Lindh via e-post johanna.lindh@fresenius-kabi.com.\u00a0\r\nF\u00f6r fackliga kontaktpersoner kan du mejla till\u00a0unionen-klubben@fresenius-kabi.com\u00a0f\u00f6r kontakt med Unionen och till\u00a0akademikerforeningen@fresenius-kabi.com f\u00f6r kontakt med Akademikerf\u00f6reningen.\nVarmt v\u00e4lkommen med din ans\u00f6kan via l\u00e4nken. Vi tar tyv\u00e4rr inte emot ans\u00f6kningar via e-mail eller post.\r\nUrval och intervjuer sker l\u00f6pande. Tills\u00e4ttning kan komma att ske innan sista ans\u00f6kningsdag, tveka inte att skicka in din ans\u00f6kan redan idag!\nI v\u00e5r rekryteringsprocess ing\u00e5r tester, intervjuer, referenstagning samt bakgrundskontroll. Vid intervju ber vi dig uppvisa examensbetyg och relevanta intyg. F\u00f6r slutkandidat genomf\u00f6rs en nyanst\u00e4llningsunders\u00f6kning hos v\u00e5r f\u00f6retagsh\u00e4lsov\u00e5rd.\n\u00a0\nAnst\u00e4llningsform: Tillsvidareanst\u00e4llning.\r\nVaraktighet: Tillsvidare.","price":null,"currency":"SEK","status":"active","noindex":true,"location":{"address":"Rapsgatan 7","full_address":null,"city":"Uppsala","country":"SE","latitude":59.8520701,"longitude":17.7188369},"metadata":{"region":"Uppsala l\u00e4n","duration":"Tills vidare","employer":"Fresenius Kabi AB","postcode":"75174","positions":1,"profession":"Regulatorisk handl\u00e4ggare\/Regulatory affairs specialist","salary_type":"Fast m\u00e5nads- vecko- eller timl\u00f6n","scope_of_work":"100\u2013100 %","working_hours":"Heltid","contact_person":"Johanna   Lind","employment_type":"full_time","occupation_field":"Naturvetenskap","employer_workplace":"Fresenius-Kabi AB, Fresenius Kabi AB","experience_required":true,"employment_type_label":"Vanlig anst\u00e4llning"},"user_id":null,"is_sponsored":false,"views_count":4,"ai_views_count":13,"bot_views_count":0,"ai_vendor_counts":{"meta":5,"other":4,"openai":1,"anthropic":3},"visibility":"public","submission_source":null,"submission_ai_name":null,"has_owner_email":true,"can_contact_owner":true,"phone":null,"owner_email":"johanna.lindh@fresenius-kabi.com","images":[],"published_at":"2026-09-03T12:25:01+00:00","expires_at":"2026-09-24T23:59:59+00:00","created_at":"2026-09-04T03:19:41+00:00","updated_at":"2026-09-18T02:53:03+00:00"}}