Inženir zagonov in kvalifikacij (d/ž/m) / (Senior) C&Q Engineer (d/f/m)
Lek, a Sandoz companySlovenia21 hours ago
Full-timeEngineering, Information Technology
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V Leku na ljubljanski lokaciji gradimo enega največjih in tehnološko najbolj naprednih biofarmacevtskih centrov za razvoj in proizvodnjo kliničnih in komercialnih serij bioloških učinkovin. Projekt temelji na najsodobnejši biofarmacevtski tehnologiji in predstavlja pomemben del globalne strategije Sandoza za razvoj in proizvodnjo podobnih bioloških zdravil. V tem centru bodo nastajali izdelki, ki z naprednimi procesi in inovativnimi pristopi pomembno prispevajo k izboljšanju kakovosti življenja pacientov po svetu ter uresničujejo naše poslanstvo zagotavljati kakovostna in dostopna zdravila.
Iščemo inženirja zagonov in kvalifikacij, ki bo imel pomembno vlogo pri uvajnaju, zagonu in kvalifikaciji nove opreme ter sistemov v najsodobnejši proizvodnji. Oseba bo sodelovala pri pripravi uporabniških zahtev ter določanju ključnih kakovostnih in tehničnih parametrov, ki jih je potrebno preveriti pri delovanju opreme (npr. bioreaktorjev, merilnih sond, avtomatike, IT‑povezav). Vaša ključna naloga bo postaviti strategijo zagonov in kvalifikacij, vključno s pristopi testiranj, prioritetami in zahtevami za dokumentacijo. Skrbeli boste da bodo kvalifikacije pravilno in pravočasno izvedene. V tej vlogi boste povezovali inženiring, procesne ekipe in QA ter skrbeli, da nova oprema omogoča varen, zanesljiv in skladen proizvodni proces.
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.
Možne lokacije dela: Ljubljana (Slovenija)
Z izbranim kandidatom bomo sklenili delovno razmerje nedoločen čas, s poskusno dobo 6 mesecev.
Prijave z življenjepisom lahko oddate najkasneje do 12.4.2026 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.
#Sandoz
________________________________________________
At the Lek’s Ljubljana site, we are building one of the largest and most technologically advanced biopharmaceutical centers for the development and production of clinical and commercial batches in Slovenia. The project is based on state‑of‑the‑art biopharmaceutical technology and represents an important part of Sandoz’s global strategy for the development and manufacturing of biosimilar medicines. In this center, products will be created using advanced processes and innovative approaches, significantly contributing to improving the quality of life for patients around the world and fulfilling our mission to provide high‑quality and accessible medicines.
We are looking for a Commissioning & Qualification Engineer who will play a key role in the introduction, start‑up, and qualification of new equipment and systems in a state‑of‑the‑art manufacturing environment. The selected candidate will participate in preparing User Requirement Specifications (URS) and defining the key quality and technical parameters that must be verified during equipment operation (e.g., bioreactors, measurement probes, automation systems, IT connections).
Your primary responsibility will be to establish the commissioning and qualification strategy, including testing approaches, priorities, and documentation requirements. You will ensure that all qualification activities are executed correctly and on time.
In this role, you will collaborate closely with engineering, process teams, and QA to ensure that all new equipment supports a safe, reliable, and compliant manufacturing process.
Your Key Responsibilities
Your responsibilities include, but not limited to:
What You Will Bring To The Role
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.
Possible job locations: Ljubljana (Slovenia)
We offer permanent contract with 6-month of probation period. You are kindly invited to submit your application, including CV, by 12.04.2026.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. In delivering over 900 million treatments with Sandoz medicines to patients around the world, 20,000 people of more than 100 nationalities are involved. 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.
#Sandoz
Iščemo inženirja zagonov in kvalifikacij, ki bo imel pomembno vlogo pri uvajnaju, zagonu in kvalifikaciji nove opreme ter sistemov v najsodobnejši proizvodnji. Oseba bo sodelovala pri pripravi uporabniških zahtev ter določanju ključnih kakovostnih in tehničnih parametrov, ki jih je potrebno preveriti pri delovanju opreme (npr. bioreaktorjev, merilnih sond, avtomatike, IT‑povezav). Vaša ključna naloga bo postaviti strategijo zagonov in kvalifikacij, vključno s pristopi testiranj, prioritetami in zahtevami za dokumentacijo. Skrbeli boste da bodo kvalifikacije pravilno in pravočasno izvedene. V tej vlogi boste povezovali inženiring, procesne ekipe in QA ter skrbeli, da nova oprema omogoča varen, zanesljiv in skladen proizvodni proces.
Vaše Ključne Odgovornosti
- Priprava uporabniških zahtev, definicija ključnih tehničnih in kakovostnih parametrov posamezne opreme in celotnih sistemov.
- Postavitev strategije zagonov in kvalifikacij opreme ter skrb, da so kvalifikacijske aktivnosti pravočasno in kvalitetno izvedene.
- Spodbujanje optimizacije procesov, nenehnih izboljšav, operativne odličnosti, inovacij, proaktivna skrb za skladnost.
- Zagotavljanje, da so vse dejavnosti v skladu s trenutnimi dobrimi praksami (cGxP), ter v skladu z integriteto podatkov.
- Sodelovanje pri strateških dejavnostih, projektih, odločitvah, zagotavljanje najsodobnejših proizvodnih in laboratorijskih procesov.
- Skrb za timsko delo, delitev znanja in izkušenj, uporabljanje široke baze znanja z različnih področij in aplikacija teh znanj na projektu.
- Izvajanje aktivnosti v skladu s sistemom kakovosti v Leku, ki je skladen s slovensko in evropsko zakonodajo, FDA, mednarodnim svetom za usklajevanje tehničnih zahtev glede zdravil, Konvencijo o farmacevtski inšpekciji in Sandozovimi standardi.
- Udeležba na vseh usposabljanjih oz. izobraževanjih, ki so zahtevana za delovno mesto, shranjevanje ustreznih dokazil o usposabljanju.
- Visokošolska stopnja izobrazbe farmacevtske, biološke, kemijske, mikrobiološke ali druge ustrezne naravoslovne smeri
- Minimalno 3 leta delovnih izkušenj na področju proizvodnje, razvoja ali druge strokovne izkušnje na področju kakovosti
- Napredna raven znanja angleškega jezika. Znanje slovenskega jezika je zaželjeno.
- Poznavanje MS Office.
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: Ljubljana (Slovenija)
Z izbranim kandidatom bomo sklenili delovno razmerje nedoločen čas, s poskusno dobo 6 mesecev.
Prijave z življenjepisom lahko oddate najkasneje do 12.4.2026 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.
#Sandoz
________________________________________________
At the Lek’s Ljubljana site, we are building one of the largest and most technologically advanced biopharmaceutical centers for the development and production of clinical and commercial batches in Slovenia. The project is based on state‑of‑the‑art biopharmaceutical technology and represents an important part of Sandoz’s global strategy for the development and manufacturing of biosimilar medicines. In this center, products will be created using advanced processes and innovative approaches, significantly contributing to improving the quality of life for patients around the world and fulfilling our mission to provide high‑quality and accessible medicines.
We are looking for a Commissioning & Qualification Engineer who will play a key role in the introduction, start‑up, and qualification of new equipment and systems in a state‑of‑the‑art manufacturing environment. The selected candidate will participate in preparing User Requirement Specifications (URS) and defining the key quality and technical parameters that must be verified during equipment operation (e.g., bioreactors, measurement probes, automation systems, IT connections).
Your primary responsibility will be to establish the commissioning and qualification strategy, including testing approaches, priorities, and documentation requirements. You will ensure that all qualification activities are executed correctly and on time.
In this role, you will collaborate closely with engineering, process teams, and QA to ensure that all new equipment supports a safe, reliable, and compliant manufacturing process.
Your Key Responsibilities
Your responsibilities include, but not limited to:
- Preparation of User Requirement Specifications (URS) and definition of key technical and quality parameters for individual equipment and entire systems.
- Establishing the strategy for equipment commissioning and qualification, and ensuring that all qualification activities are completed on time and with high quality.
- Driving process optimization, continuous improvement, operational excellence, innovation, and proactively ensuring compliance.
- Ensuring that all activities are performed in accordance with current good practices (cGxP) and data integrity requirements.
- Participation in strategic activities, projects, and decision-making, contributing to state-of-the-art manufacturing and laboratory processes.
- Fostering teamwork, knowledge sharing, and the use of broad cross-functional expertise, and applying this knowledge within the project.
- Performing activities in accordance with the Lek quality system, aligned with Slovenian and European legislation, FDA requirements, ICH guidelines, the Pharmaceutical Inspection Co-operation Scheme (PIC/S), and Sandoz standards.
- Participation in all required trainings and education programs for the position and maintaining appropriate training records.
What You Will Bring To The Role
- University degree in pharmacy, biology, chemistry, microbiology other equivalent natural or engineering science degree
- Minimum 3 years of experience in production, development or other quality functions on expert position
- Advanced level in English is required. Knowledge of Slovene is a plus.
- Knowledge of MS Office.
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.
Possible job locations: Ljubljana (Slovenia)
We offer permanent contract with 6-month of probation period. You are kindly invited to submit your application, including CV, by 12.04.2026.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. In delivering over 900 million treatments with Sandoz medicines to patients around the world, 20,000 people of more than 100 nationalities are involved. 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.
#Sandoz
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