C&Q engineer I (d/f/m) / Inženir zagonov in kvalifikacij - ekspert

With its strategic investments in Slovenia, Sandoz is not just building factories, but shaping the future – for science, for people, and for global healthcare. To realize this vision, we need dedicated, motivated, and passionate professionals who will co-create a success story with their knowledge and commitment.

Manufacturing unit Bio Injectable products Brnik will provide advanced pharmaceutical products to patients around the world. We are increasingly focusing on biosimilars, which require exceptional quality of processes and procedures, and above all, high professionalism, dedication and commitment of all employees in the unit.

As a C&Q Engineer I (d/f/m) you will be responsible for planning, executing and preparing reports related to the start‑up and qualification of equipment, facilities and processes. This role includes supporting both investment projects in equipment and infrastructure, as well as routine production activities, while ensuring that all procedures are carried out in accordance with established good practices in the pharmaceutical industry.

Your Responsibilities Include, But Not Limited To

• Supporting internal and external assessments, including audits and inspections, as well as sharing and applying best practices in start‑up and qualification activities.
• Developing, implementing, and maintaining operational and standard procedures, and ensuring appropriate training for employees.
• Planning and managing project documentation, including timelines, risk assessments, quality plans and proper archiving of project records.
• Performing technical inspections and equipment tests, such as factory and site acceptance tests, and assessing safety, durability and constructability.
• Leading change management and handling deviations, including root‑cause analysis and implementation of corrective actions.
• Collaborating with suppliers and contractors, overseeing their work, coordinating activities, and ensuring compliance with safety and inspection requirements.
• Planning and supervising maintenance and calibration activities, including task allocation, compliance checks and assessing impacts on equipment quality.
• Executing qualification activities, from protocol preparation to execution and reporting, including periodic requalification and support during validation.
  
  

What Will You Bring To The Role

• Degree in engineering (Dipl. Ing. / M. Sc. / B. Sc.) or equivalent.
• Minimum 3 years of experience in engineering project / commissioning / qualification / compliance in pharmaceutical industry.
• Fluent in English and proficient in local language. Knowledge of Microsoft Office.
  
  

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.

Possible job locations: Ljubljana and Brnik, Slovenia.

We are offering a permanent contract with a 6-month probation period.

You are kindly invited to submit your application, including your CV, by 28.02.2026.

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.

Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: https://talentnetwork.novartis.com/sandoztalentpool

#Sandoz

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Sandoz s svojimi strateškimi investicijami v Sloveniji ne gradi le tovarn, temveč prihodnost – za znanost, za ljudi in za globalno zdravstvo. Da bi to vizijo uresničili, potrebujemo zavzete, motivirane in srčne strokovnjake, ki bodo s svojim znanjem in predanostjo soustvarjali zgodbo uspeha.

Proizvodna enota bioinjektabilnih izdelkov na Brniku bo zagotavljala napredne farmacevtske izdelke bolnikom po vsem svetu. Pri tem se vse bolj usmerjamo na podobna biološka zdravila, ki zahtevajo izjemno kakovost procesov in postopkov, predvsem pa visoko strokovnost, predanost in zavzetost vseh zaposlenih na enoti.

Kot Inženir za zagone in kvalifikacije – ekspert (d/ž/m) boste odgovorni za načrtovanje, izvedbo in pripravo poročil o zagonu ter preverjanju usposobljenosti opreme, objektov in procesov. Slednje vključuje podporo tako investicijskim projektom v opremo in infrastrukturo kot tudi rednim proizvodnim dejavnostim, pri čemer boste zagotavljali, da so vsi postopki izvedeni skladno z uveljavljenimi dobrimi praksami v farmacevtski industriji.

Vaše Ključne Odgovornosti

• Podpora pri pregledih in nadzorih, vključno z notranjimi in zunanjimi presojami ter izmenjavo dobrih praks na področju zagonov in kvalifikacij.
• Razvoj, izvajanje in vzdrževanje operativnih in standardnih postopkov, skupaj z zagotavljanjem ustreznega usposabljanja zaposlenih.
• Načrtovanje in vodenje projektne dokumentacije, vključno s časovnicami, ocenami tveganj, načrti kakovosti ter arhiviranjem projektnih zapisov.
• Izvajanje tehničnih pregledov in testov nove opreme, kot so tovarniški in lokacijski preizkusi, ter ocenjevanje varnosti, trajnosti in izvedljivosti.
• Vodenje postopkov sprememb in obravnava odstopanj, vključno z analiziranjem vzrokov in izvedbo korektivnih ukrepov.
• Sodelovanje z dobavitelji in izvajalci, kar vključuje nadzor nad njihovim delom, usklajevanje aktivnosti ter zagotavljanje varnostnih in inšpekcijskih zahtev.
• Načrtovanje in nadzor vzdrževalnih ter kalibracijskih aktivnosti, vključno z dodeljevanjem nalog, preverjanjem skladnosti in ocenjevanjem vpliva na kakovost.
• Izvajanje kvalifikacijskih aktivnosti, od priprave protokolov do izvedbe in poročanja, skupaj s periodičnim ponovnim preverjanjem ter podporo med validacijami.
  
  

Vaš Doprinos k Delovnem Mestu

• Visokošolska izobrazba tehnične ali druge ustrezne smeri.
• Minimalno 3 leta relevantnih izkušenj na področju projektov v inženiringu, zagonih obratovanja, kvalifikacijah in skladnosti v farmacevtski industriji.
• Tekoče znanje angleškega jezika in znanje lokalnega jezika. Poznavanje orodja Microsoft Office.
  
  

Kaj nudimo

Zaposlitev pri najuglednejšem delodajalcu v Sloveniji vam prinaša konkurenčen plačni paket, letni bonus, fleksibilen način dela z možnostjo prilagajanja urnika in občasnim 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.

Možna lokacija zaposlitve: Ljubljana in Brnik, Slovenija.

Z izbranim kandidatom bomo sklenili delovno razmerje za nedoločen čas s poskusno dobo 6 mesecev.

Prijave z življenjepisom v slovenskem jeziku lahko oddate najkasneje do 28.02.2026 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