Tehnolog proizvodnih procesov - Specialist (Inokulum in pakiranje učinkovine) (d/ž/m) / Senior Process Expert - Inoculum and DS Dispensing (d/f/m)
Lek, a Sandoz companySlovenia5 days ago
Full-timeRemote FriendlyOther
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Job Description
Kot Tehnolog proizvodnih procesov specialist – Inokulum in pakiranje učinkovine boste odgovorni za zagotavljanje zahtevnejše strokovne pomoči proizvodnji, obvladovanje in optimizacije zahtevnejših proizvodnih procesov ter upravljanje zahtevnejših procesnih tehnologij in izdelkov. To vključuje tudi sodelovanje pri stalnem izboljševanju kakovosti in produktivnosti, v skladu s trenutno veljavnimi GMP, SPji ter veljavnimi smernicami in funkcijskimi standardi (npr. ZVO) in podporo nemotenemu delovanju proizvodnje, s ciljem izboljšati kakovost in skladnost.
Pridružite se nam pri soustvarjanju "novega" Sandoza in Leka!
Vaše Ključne Odgovornosti
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.
Lokacija 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 2.01.2026 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
__________________________________________________________________________________________________________________
As Senior Process Expert - Inoculum and DS Dispensing you will be responsible for the front line complex expert support for all process-specific issues to production within one or more complex production steps, to ensure execution of complex processes on-time, continuously improving in quality and productivity, performed in compliance to cGMPs, SOPs and applicable guidelines and functional standards (e.g. HSE...). You will support smooth operation of production, with the aim of improving quality and compliance and you will be responsible for upgrading and transfer of expertise, assessment and implementation of new technologies, and contribution to the development process optimization
Join us as a Founder of our ‘new’ Sandoz and Lek!
Your Key Responsibilities
Your responsibilities include, but not limited to:
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 locations: Lendava, Slovenia
We offer permanent contract with 6-month of probation period. You are kindly invited to submit your application in English language, including CV, by 2.01.2026.
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
Kot Tehnolog proizvodnih procesov specialist – Inokulum in pakiranje učinkovine boste odgovorni za zagotavljanje zahtevnejše strokovne pomoči proizvodnji, obvladovanje in optimizacije zahtevnejših proizvodnih procesov ter upravljanje zahtevnejših procesnih tehnologij in izdelkov. To vključuje tudi sodelovanje pri stalnem izboljševanju kakovosti in produktivnosti, v skladu s trenutno veljavnimi GMP, SPji ter veljavnimi smernicami in funkcijskimi standardi (npr. ZVO) in podporo nemotenemu delovanju proizvodnje, s ciljem izboljšati kakovost in skladnost.
Pridružite se nam pri soustvarjanju "novega" Sandoza in Leka!
Vaše Ključne Odgovornosti
- Opravljanje vloge strokovnjaka na svojem področju (SME) za specifične tehnike, izdelke ali tehnološke procese pri proizvodnji bioloških zdravil. Predvsem dobro poznavanje specifik dela s sesalskimi celicami ter prenos znanja v proizvodno okolje.
- Poznavanje zahtev in dela v čistih prostorih (klasa A, B in C) ter zagotavljanje skladnosti postopkov z regulativo.
- Sodelovanje pri projektih avtomatizacije procesov priprave inokulumov in pakiranja učinkovin ter implementaciji digitalnih rešitev za povečanje učinkovitosti in zanesljivosti proizvodnje, vključujoč vpeljavo eBR.
- Usklajevanje in zagotavljanje pravočasnega dokončanja vseh proizvodnih postopkov v skladu z dokumentacijo in pravili dobre proizvodne prakse (GMP).
- Zagotavljanje pravočasne strokovne podpore proizvodnji v primeru tehničnih težav in skrb za takojšnje izvajanje ustreznih korektivnih ukrepov.
- Spremljanje najkompleksnejših procesov in ugotavljanje morebitnih trendov ter pravočasno ukrepanje ob opaženih negativnih trendih.
- Zagotavljanje sistematičnega ter pravočasnega posodabljanja najkompleksnejše proizvodne dokumentacije za potrebe redne proizvodnje, projektnih časovnic in/ali validacij skladno z zahtevami GMP.
- Skrb za prenos informacij in povečanje ozaveščenosti timov v proizvodnji ob težavah ali spremembah, ki imajo vpliv na tehnične dejavnike, kakovost ali ZVO.
- Univerzitetna diploma/magisterij iz inženiringa, farmacevtske tehnologije, kemije, farmacije ali druge ustrezne znanstvene smeri
- Zaželen magisterij ali ustrezne izkušnje iz proizvodnje bioloških zdravil
- Aktivno znanje angleškega jezika in znanje lokalnega jezik.
- Minimalno 5 let delovnih izkušenj na delovnih mestih za podporo procesom v proizvodnji in/ali kakovosti
- Poznavanje procesov (farmacevtska proizvodnja bioloških zdravil, GMP, regulatorni vidiki)
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.
Lokacija 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 2.01.2026 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
__________________________________________________________________________________________________________________
As Senior Process Expert - Inoculum and DS Dispensing you will be responsible for the front line complex expert support for all process-specific issues to production within one or more complex production steps, to ensure execution of complex processes on-time, continuously improving in quality and productivity, performed in compliance to cGMPs, SOPs and applicable guidelines and functional standards (e.g. HSE...). You will support smooth operation of production, with the aim of improving quality and compliance and you will be responsible for upgrading and transfer of expertise, assessment and implementation of new technologies, and contribution to the development process optimization
Join us as a Founder of our ‘new’ Sandoz and Lek!
Your Key Responsibilities
Your responsibilities include, but not limited to:
- Acting as a Subject Matter Expert (SME) in your field for specific techniques, products, or technological processes in the manufacturing of biological medicines. This includes strong knowledge of working with mammalian cells and transferring expertise into the production environment.
- Understanding the requirements and work in cleanrooms (Class A, B, and C) and ensuring process compliance with regulatory standards.
- Participating in projects related to process automation for inoculum preparation and active ingredient packaging, as well as implementing digital solutions to improve efficiency and reliability in manufacturing, including the introduction of eBR.
- Coordinating and ensuring timely completion of all manufacturing processes in accordance with documentation and Good Manufacturing Practice (GMP) standards.
- Providing timely technical support to production in case of technical issues and ensuring immediate implementation of appropriate corrective actions.
- Monitoring the most complex processes, identifying potential trends, and taking timely action in response to observed negative trends.
- Ensuring systematic and timely updates of the most complex manufacturing documentation for routine production, project timelines, and/or validations in compliance with GMP requirements.
- Facilitating information transfer and raising awareness among production teams regarding issues or changes that impact technical factors, quality, or environmental health and safety (HSE).
- BSc./MSc degree in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree.
- Desirable MSc. or equivalent experience of the production of biosimilars Fluent in English and proficient in site local language
- Minimum 5 year experience in process support role on the shop floor of
- manufacturing and/or quality.
- Process understanding (Pharma biosimilars, GMP, Regulatory aspects).
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 locations: Lendava, Slovenia
We offer permanent contract with 6-month of probation period. You are kindly invited to submit your application in English language, including CV, by 2.01.2026.
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
Key Skills
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