C&Q engineer II (d/f/m) / Inženir zagonov in kvalifikacij (d/ž/m)

Job Description Summary

The future is ours to shape. / Prihodnost je v naših rokah.

Job Description

Sandoz is shaping the future of the pharmaceutical industry through strategic investments in Slovenia. The new Brnik site, one of the largest current investments in the sector, will manufacture advanced injectable biologic medicines for patients around the world. We are seeking motivated and dedicated professionals who want to be part of a project with a long-term impact on healthcare, science, and patients’ quality of life.

As a C&Q Engineer II (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 1 year of experience in engineering project / commissioning / qualification / compliance in pharmaceutical industry.
• Fluent in English and proficient in local language.
• Knowledge of Microsoft Office.

What we offer:

• Job location: Ljubljana and Brnik, Slovenia
• Contract type: permanent contract with 6-month probation period
• Expected weekly working hours: 40
• *Pay range: 32.400 - 48.600 EUR gross

*Salary at Sandoz is based on job level, qualifications, specific skills, and work experience. Fully proficient candidates are usually placed around the market median, less experienced candidates lower in the range, and those with strong or niche expertise higher. When determining placement within the range, we also consider internal pay equity and external market data.

Our compensation package additionally includes:

• Annual bonus (STI): percentage of annual salary
• Vacation allowance: in 2026 it was €2,450.00 net
• Christmas bonus: in 2025 it was €2,100 gross
• OurShare: every year, an employee of Lek d.d. will be entitled to receive shares of Sandoz AG
• Voluntary Additional Pension Scheme: The company fully covers the contribution for your supplementary pension plan, amounting to 5.844% of your gross salary
• Allowance for shift work (15%); rotational shifts (20%), night shift work (70%), Sunday/public holiday work (50%), overtime work (30%) – if applicable for position
• Collective life and accident insurance (24/7 coverage)
• A hybrid work environment offering flexibility and remote work possibilities – if applicable for position

Ready for your next career move?

You are kindly invited to submit your application in English and Slovene, including a CV, by 04. 10. 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 strateškimi investicijami v Sloveniji soustvarja prihodnost farmacevtske industrije. Nova lokacija na Brniku, ena največjih trenutnih investicij v panogi, bo zagotavljala napredna bioinjektabilna zdravila za bolnike po vsem svetu. Iščemo motivirane in predane strokovnjake, ki želijo biti del projekta z dolgoročnim vplivom na zdravstvo, znanost in kakovost življenja pacientov.

Kot Inženir za zagone in kvalifikacije (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 1 leto 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:

• Lokacija dela: Ljubljana in Brnik, Slovenija
• Vrsta pogodbe: pogodba za nedoločen čas s 6-mesečnim poskusnim obdobjem
• Predvideni tedenski delovni čas: 40 ur/teden
• *Plačni razpon: 32.400 - 48.600 EUR bruto

* Plača v Sandozu temelji na nivoju delovnega mesta, kvalifikacijah, specifičnih veščinah in znanjih ter delovnih izkušnjah. Visoko usposobljeni kandidati so običajno umeščeni okoli mediane plačnega razpona, manj izkušeni na spodnji del razpona, kandidati z izrazito močnimi ali nišnimi kompetencami pa višje. Pri umeščanju v plačni razpon upoštevamo tudi notranjo uravnoteženost plač in zunanje tržne podatke.

Naš paket ugodnosti dodatno vključuje:

• Letni bonus (STI): odstotek letne plače.
• Regres za letni dopust: leta 2026 je znašal 2.440,00 EUR (neto).
• Božičnica: leta 2025 je znašala 2.100 EUR (bruto).
• OurShare: Vsako leto bo zaposleni v družbi Lek d.d. upravičen do prejema delnic družbe Sandoz AG.
• Prostovoljno dodatno pokojninsko zavarovanje: družba Lek d.d. v celoti krije mesečni prispevek za dodatno pokojninsko zavarovanje v višini 5,844 % vaše mesečne bruto plače.
• Dodatek za izmensko delo (15 %); turnusno delo (20 %), nočno delo (70 %), delo ob nedeljah in praznikih (50 %), nadurno delo (30 %) – če to velja za zadevno delovno mesto.
• Kolektivno življenjsko in nezgodno zavarovanje (kritje velja 24/7).
• Hibridno delovno okolje, ki omogoča fleksibilnost in možnost dela na daljavo. – če to velja za zadevno delovno mesto.

Ste pripravljeni na naslednji korak v karieri?

Prijavo z življenjepisom v angleškem in slovenskem jeziku lahko oddate najpozneje do 04. 10. 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

Skills Desired

Assembly Language, Change Control, Chemical Engineering, Chemistry, Continual Improvement Process, Cost Reduction, Data Analytics, Electronic Components, General Hse Knowledge  , Including Gdp, Knowledge Of Capa, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Pharmaceutics, Process and Cleaning Validation, Process Control, Process Engineering, Risk Management, Root Cause Analysis (RCA), Scheduler, Six Sigma, Sop (Standard Operating Procedure)