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Job Description Summary The future is ours to shape. / Prihodnost je v naših rokah. Job Description For the new large scale Biopharmaceuticals DS production facility at Lek in Lendava, we are currently seeking Validation Experts with experience in Upstream and / or Downstream Bioprocessing. Join us as a Validation Expert and be the key to ensuring our biopharmaceutical products meet the highest quality standards. You'll lead crucial validation projects for bioprocesses, keeping us compliant with global regulations and driving continuous improvement. If you're passionate about precision and quality, and want to make a real impact, we want you on our team. Join us as a Founder of our ‘new’ Sandoz and Lek! Your key responsibilities: Your responsibilities include, but not limited to: Author and review process, and cleaning validation plans, protocols & reports, for initial validation and/or ongoing process verification (OPV). Participate in pre-validation activities and risk assessments to ensure the success of commercial process validation and lead the execution of validation activities on the shop floor. Participate in the Tech Transfer teams, under project leadership of the Tech Transfer leads, as core member for process validation. Work in close collaboration with the sending site (development organization or production facility) for new product launches and site to site technical transfers ensuring that knowledge is transferred, control strategies are appropriate, risks are analysed and controlled and commercial processes are validation ready. Actively participate in defining and implementing the validation strategy for production and cleaning process, for both for initial validation and Ongoing Process or Cleaning verification (OPC, OCV) as well as advocacy to the relevant authorities. Support Product Stewards in maintaining the process control strategy. Translate applicable process parameters and the process control strategy into a focused validation plan for process validation. Support process validation lifecycle activities by ensuring a state of control is maintained through ongoing process verification (OPV). Ensure that appropriate variables are identified for on-going monitoring. Support validation lead for KPI reporting. Ensure that all Site validation activities are performed and are in line with requirements and cGMP, manage deviations associated with process validation and makes recommendations for deviation resolution as well as prevention of reoccurrence. What you will bring to the role: Minimum 4-6 years of relevant experience in biomanufacturing, technical development, MS&T or Quality, with a focus on validation of large scale mammalian or microbial drug substance manufacturing. Proven expertise with Process and Cleaning validation in large scale mammalian or microbial Drug substance production facilities. BSc. in Pharmacy, Pharmaceutical Technology, Biochemistry, Chemical Engineering, or a related scientific discipline. MSc or equivalent is preferred. Understanding of regulatory requirements, process validation, continued process verification, and cGMP. Good communication and presentation skills. Ability to work independently and manage time effectively. Good knowledge of English, both in speaking and writing. Knowledge of the local language is a plus. You’ll receive: Employment at the most reputable employer in Slovenia offers Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical, mental and social well-being (WellBeat), Unlimited learning and development opportunities. Job location: Lendava, Slovenia We offer a permanent contract with a 6-month probation period. You are kindly invited to submit your application in English, including your CV, by April 12th, 2026. Why Sandoz? Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more! With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably. Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged! The future is ours to shape! Commitment to Diversity & Inclusion: Sandoz is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve. #BIORampUp #Sandoz ______________________________________________________________________________ Za novo veliko proizvodno enoto za proizvodnjo učinkovin za podobna biološka zdravila (Drug Substance) v Lendavi iščemo strokovnjake za validacijo z izkušnjami na področju Upstream in/ali Downstream bioprocesov. Pridružite se nam kot Ekspert validacij in postanite ključni člen pri zagotavljanju, da naši izdelki dosegajo najvišje standarde kakovosti. Vodili boste ključne validacijske projekte za bioprocesne postopke, skrbeli za skladnost z globalnimi predpisi ter spodbujali stalne izboljšave. Če cenite natančnost in kakovost ter želite prispevati k pomembnim dosežkom, potem ste prava oseba za našo ekipo! Vaše ključne odgovornosti: Priprava in pregled postopkov ter načrtov, protokolov in poročil za validacijo čiščenja in procesov, tako za začetno validacijo kot za stalno preverjanje procesov (OPV). Sodelovanje pri predvalidacijskih aktivnostih in oceni tveganj, da se zagotovi uspešna komercialna validacija procesov, ter vodenje izvajanja validacijskih aktivnosti v proizvodnem obratu. Aktivno sodelovanje v ekipah za tehnični prenos pod vodstvom vodij tehničnega prenosa kot ključni član za validacijo procesov. Tesno sodelovanje s pošiljajočo lokacijo (razvojna organizacija ali proizvodni obrat) pri lansiranju novih izdelkov in tehničnih prenosih med lokacijami, s čimer se zagotovi prenos znanja, ustreznost kontrolnih strategij, analiza in obvladovanje tveganj ter pripravljenost komercialnih procesov na validacijo. Aktivno sodelovanje pri opredelitvi in implementaciji strategije validacije za proizvodne in čistilne procese, tako za začetno validacijo kot za stalno preverjanje procesov ali čiščenja (OPC, OCV), ter zastopanje pri pristojnih organih. Podpora skrbnikom izdelkov pri vzdrževanju strategije procesnega nadzora. Pretvorba ustreznih procesnih parametrov in strategije nadzora v ciljno usmerjen validacijski načrt za validacijo procesov. Podpora aktivnostim življenjskega cikla validacije procesov z zagotavljanjem stanja nadzora prek stalnega preverjanja procesov (OPV). Zagotovitev identifikacije ustreznih spremenljivk za stalno spremljanje. Podpora vodji validacije pri poročanju o ključnih kazalnikih uspešnosti (KPI). Zagotavljanje, da so vse validacijske aktivnosti na lokaciji izvedene skladno z zahtevami in cGMP, upravljanje odstopanj, povezanih z validacijo procesov, ter podajanje priporočil za njihovo reševanje in preprečevanje ponovitev. Vaš doprinos k delovnem mestu: Najmanj 4–6 let ustreznih izkušenj na področju bioproizvodnje, tehničnega razvoja, MS&T ali kakovosti, s poudarkom na validaciji proizvodnje učinkovin iz sesalskih ali mikrobnih celic na veliki skali. Dokazana strokovnost na področju validacije procesov in čiščenja v obratih za proizvodnjo učinkovin iz sesalskih ali mikrobnih celic na veliki skali. Diploma iz farmacije, farmacevtske tehnologije, biokemije, kemijskega inženirstva ali sorodne znanstvene discipline; zaželena je magistrska stopnja ali enakovredna izobrazba. Razumevanje regulatornih zahtev, validacije procesov, stalnega preverjanja procesov in cGMP. Dobre komunikacijske in predstavitvene veščine. Sposobnost samostojnega dela in učinkovitega upravljanja časa. Dobro znanje angleškega jezika (ustno in pisno), znanje lokalnega jezika je prednost. Kaj nudimo: Zaposlitev pri najuglednejšem delodajalcu v Sloveniji vam prinaša konkurenčen plačni paket, letni bonus, fleksibilen način dela z možnostjo prilagajanja urnika in delom od doma, pokojninsko shemo, shemo nagrajevanja in priznanja dosežkov, razširjeni program promocije zdravja na področju telesnega, duševnega in družbenega počutja (DobroBit) ter dogodke, neomejene priložnosti za učenje in razvoj. Možne lokacije dela: Lendava, Slovenija Z izbranim kandidatom bomo sklenili delovno razmerje nedoločen čas s poskusno dobo 6 mesecev. Prijave z življenjepisom v angleškem in slovenskem jeziku lahko oddate najkasneje do 12. aprila 2026 preko spletne povezave. Zakaj Sandoz in Lek? Generična in podobna biološka zdravila so hrbtenica svetovne industrije zdravil. Sandoz se je kot vodilni v tem sektorju lani dotaknil življenj skoraj 500 milijonov bolnikov. Na ta dosežek smo ponosni, a si želimo še več! Z naložbami v nove razvojne zmogljivosti, najsodobnejše proizvodne lokacije, nove pridobitve in partnerstva imamo priložnost oblikovati prihodnost Sandoza in Leka ter še večjemu številu bolnikov omogočiti trajnostni dostop do cenovno ugodnih in visokokakovostnih zdravil. Naša zagon in podjetniški duh temeljita na odprti kulturi sodelovanja, katere srce so naši talentirani in ambiciozni sodelavci in sodelavke. V okolju, kjer je raznolikost dobrodošla in kjer se spodbuja osebna rast, imajo v zameno za uporabo svojih znanj, možnost v celoti izkusiti delo v agilnem in povezovalnem okolju in z možnostjo fleksibilnega in hibridnega dela razvijati svojo kariero. Prihodnost je v naših rokah! Predani smo raznolikosti in vključenosti: Sandoz se zavzema za raznolikost, enake možnosti in vključenost. Prizadevamo si za oblikovanje raznolikih timov, saj ti predstavljajo naše bolnike in skupnosti, ki jih oskrbujemo. #BioRampUp #Sandoz Skills Desired Our Purpose here at Sandoz is pioneering access for patients. As the global leader in 'off-patent' high quality medicines, we are able to make medicine more affordable and accessible. Our broad global portfolio comprises of approximately 1,300 quality biosimilar and generic medicines, enabling us to provide more than 900 million patient treatments across 100+ countries per year, and while we are proud of this achievement, we have an ambition to do more! Powered by our talented and ambitious colleagues, who, in return for dedication and skills, experience a flexible, collaborative & inclusive culture where diversity of thought is welcomed and where personal growth is nurtured!