Senior Project Engineer – QC Laboratory Establishment (Biosimilars) (f/m/d) / Projektni inženir specialist za vzpostavitev QC laboratorija za biološko podobna zdravila (d/ž/m)

Job Description Summary

Prihodnost je tu, oblikujmo jo skupaj. / The future is ours to shape.

Job Description

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.

V tej vlogi boste vodili vzpostavitev najsodobnejšega QC laboratorija za proteinsko analitiko, od začetne zasnove do uspešnega operativnega zagona. Pri tem boste zagotavljali skladnost z regulatornimi zahtevami, skrbeli za pravočasno izvedbo projekta ter učinkovito usklajevali vse ključne deležnike (inženiring, HSE, razvojno analitiko in globalne funkcije Sandoz).

Vaše ključne odgovornosti:

Vaše odgovornosti bodo med drugim naslednje:

• Detajlno načrtovanje QC laboratorija (tloris) ter definiranje potrebnih kapacitet
• Načrtovanje postavitve opreme, definiranje zahtev ter izbor najsodobnejše analitske opreme
• Priprava projektne dokumentacije (URS, SIA, QP) ter dokumentacije za opremo (URS, HLRA...)
• Koordinacija nabave opreme ter izvedba kvalifikacij
• Implementacija laboratorijskih IT sistemov ter vzpostavitev brezpapirnega (paperless) in digitalnega QC okolja
• Učinkovito usklajevanje ključnih deležnikov (inženiring, HSE, QA, globalne Sandoz funkcije) za zagotavljanje regulatorne skladnosti in doseganje projektnih časovnic
• Tesno sodelovanje z oddelkom razvojne analitike za zagotavljanje harmoniziranega analitskega pristopa med rezvojem in proizvodnjo
• Širitvi ekipe ter uvajanje novo zaposlenih skladno s časovnicami projekta

Vaš prispevek k delovnemu mestu:

• Najmanj 5 let delovnih izkušenj v QC laboratoriju (na področju proteinske analitike) ter izkušnje z delom na projektih (npr. širitev laboratorija, uvajanje nove opreme, vzpostavljanje novih analitskih metod).
• Minimalno visokošolska stopnja izobrazbe naravoslovne smeri (biokemija, farmacija, biotehnologija...).
• Tekoče znanje angleškega jezika.

Kaj nudimo:

Lokacija dela: Ljubljana

Vrsta pogodbe: pogodba za nedoločen čas s 6-mesečnim poskusnim obdobjem

Predvideni tedenski delovni čas: 40

*Plačni razpon: 58.080–87.120 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 2025 je znašal 2.430,99 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
• 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 28. junij 2026.

Zakaj Sandoz?

Sandoz je vodilni svetovni proizvajalec generičnih in podobnih bioloških zdravil – segmenta zdravstvene industrije, ki zagotavlja 80 % vseh zdravil na svetu po 30-odstotni ceni ter s tem vpliva na življenja več kot milijarde ljudi v več kot 100 državah. Čeprav smo ponosni na svoje dosežke, si prizadevamo narediti še več, da bi vsakdo imel dostop do temeljne človekove pravice – pravice do dobrega zdravja.

Z naložbami v nove razvojne zmogljivosti, proizvodne lokacije, nove pridobitve in partnerstva imamo priložnost oblikovati prihodnost Sandoza ter še večjemu številu ljudi omogočiti trajnostni dostop do cenovno ugodnih in visokokakovostnih zdravil.

Naš zagon temelji na odprti kulturi sodelovanja, katere srce so naši talentirani in ambiciozni sodelavci in sodelavke. V okolju, kjer so raznoliki načini razmišljanja dobrodošli in kjer se podpira osebna rast, imajo v zameno za uporabo svojih znanj možnost v celoti izkusiti delo v agilnem in povezovalnem okolju ter razvijati svojo uspešno kariero. 

Pridružite se nam in nam pomagajte povečati pravičnost in hitrost zdravstvenega varstva.

Prihodnost je v naših rokah.

Predani smo raznolikosti in vključenosti:

Zavzemamo se 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.

In this role, you will lead the setup of a state-of-the-art QC laboratory for protein analytics, from initial design through to successful operational start-up. You will be responsible for ensuring compliance with regulatory requirements, delivering the project on time, and effectively coordinating all key stakeholders (Engineering, HSE, Development Analytics, and global Sandoz functions).

Your key responsibilities:

Your responsibilities include, but are not limited to:

• Detailed design of the QC laboratory (layout) and planning of required capacities
• Defining analytical equipment requirements, and selection of state-of-the-art analytical equipment
• Preparation of project  (URS, SIA, QP) and equipment documentation (URS, HLRA, etc.)
• Coordination of equipment procurement and execution of qualifications
• Implementation of laboratory IT systems and establishment of a paperless and digital QC environment
• Effective coordination of key stakeholders (Engineering, HSE, QA, global Sandoz functions) to ensure regulatory compliance and adherence to project timelines
• Close collaboration with the Analytical development department to ensure a harmonized analytical approach between development and manufacturing
• Team expansion and onboarding of new employees in line with project timelines

What you will bring to the role:

• At least 5 years of experience in a QC laboratory (protein analytics) and experience working on projects (e.g., laboratory expansion, introduction of new equipment, implementation of new analytical methods)
• At minimum a university degree in a natural sciences field (biochemistry, pharmacy, biotechnology, etc.)
• Fluency in English

What we offer:

Job location: Ljubljana

Contract type: permanent contract with 6-month probation period

Expected weekly working hours: 40

*Pay range: €58,080 – €87,120 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 2025 it was €2,430.99 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
• 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 June 28th 2026.

Why Sandoz?

Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have the ambition to do more so that everyone can benefit from the basic human right of good health.

With investments in new development capabilities, production sites, new acquisitions and partnerships, we have the opportunity to shape a sustainable future for Sandoz and to help even more people gain access to low-cost, high-quality medicines.

Our momentum 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 where diversity of thought is welcomed and where personal growth is supported! 

Join us in helping to make healthcare fairer and faster.

The future is ours to shape.

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and to forming diverse teams that are representative of the patients and communities we serve. 

  

#Sandoz

Skills Desired

Automation, Capital Expenditure, Change Management, Classification Systems, Critical Thinking, Efficiency, Flexibility, General Hse Knowledge  , Including Gdp, Knowledge Of Gmp, Manufacturing Process (Production), Operations, Root Cause Analysis (RCA), Support Services