Tehnolog proizvodnih procesov specialist DSP (d/ž/m) / Senior Process Expert DSP (d/f/m)

Job Description Summary

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

Job Description

Pridružite se eni največjih investicij v biofarmacevtsko proizvodnjo v Evropi in soustvarjajte prihodnost razvoja ter proizvodnje bioloških zdravil. V Leku na ljubljanski lokaciji gradimo enega največjih in tehnološko najnaprednejših biofarmacevtskih centrov za razvoj in proizvodnjo kliničnih in komercialnih serij bioloških učinkovin. Gre za edinstveno priložnost, da kot del strokovne projektne ekipe sodelujete pri vzpostavitvi nove generacije proizvodnih procesov in naprednih tehnologij, ki bodo pomembno soustvarjale globalno mrežo Sandoza.

Vaše ključne odgovornosti:

• Sodelovanje pri vzpostavitvi celotnega DSP procesa čiščenja bioloških učinkovin, od primarne separacije do UF/DF, končne filtracije in polnjenja.
• Prispevanje k dokumentaciji, definiranju procesnih parametrov in učinkovitemu avtomatiziranemu vodenju DSP procesa po postavitvi obrata.
• Zagotavljanje strokovne podpore za načrtovanje DSP procesa in izbora najsodobnejše opreme pri postavljanju visokotehnološkega avtomatiziranega obrata za proizvodnjo bioloških učinkovin.
• Priprava uporabniških zahtev za DSP opremo, definicija ključnih tehničnih in kakovostnih parametrov posamezne opreme in celotnih sistemov.
• Postavitev strategije testiranj opreme, zagonov in kvalifikacij DSP opreme ter skrb, da so kvalifikacijske aktivnosti pravočasno in kvalitetno izvedene.
• Spodbujanje optimizacije DSP procesov, vključitev znanja operativne odličnosti v načrtovanje DSP procesov in obrata, inovacij, proaktivna skrb za skladnost.
• 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.
• Sodelovanje s strokovnjaki MS&T pri določitvi validacijske strategije.

Vaš doprinos k delovnem mestu:

• Univerzitetna diploma iz inženiringa, farmacevtske tehnologije, kemije, farmacije ali druge ustrezne znanstvene smeri. Zaželen magisterij ali ustrezne izkušnje.
• Minimalno 2-5 let delovnih izkušenj na delovnih mestih za podporo procesom v proizvodnji in/ali kakovosti.
• Poznavanje procesov (farmacevtska proizvodnja, GMP, regulatorni vidiki).
• Napredna raven znanja angleškega jezika in odlično znanje slovenskega jezika.
• Izkušnje z DSP procesi ali biološko proizvodnjo predstavljajo prednost.
• Sposobnost analitičnega razmišljanja in sistematičnega reševanja problemov.
• Proaktivnost, samoiniciativnost ter učinkovito sodelovanje v interdisciplinarnih timih.

Kaj nudimo:

Lokacija dela: Ljubljana

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

Predvideni tedenski delovni čas: 40

*Plačni razpon: 45.120– 67.680 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. avgust 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

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At Lek, a Sandoz company, we are building one of the largest and most technologically advanced biopharmaceutical centres for the development and manufacturing of clinical and commercial-stage biologic drug substances. This landmark project combines cutting-edge technologies, digitalisation, and automation, creating a unique opportunity to contribute to the establishment of next-generation manufacturing capabilities. As part of a highly skilled project team, you will play a key role in bringing innovative processes to life and supporting the continued growth of Sandoz’s global biologics network.

Your key responsibilities: 

• Participation in establishing the complete DSP process for purification of biological drug substances, from primary separation to UF/DF, final filtration, and filling.
• Contributing to documentation development, definition of process parameters, and efficient automated control of the DSP process after facility start‑up.
• Providing technical support for the design of the DSP process and selection of state‑of‑the‑art equipment for a high‑technology automated biological drug substance manufacturing facility.
• Preparing User Requirement Specifications (URS) for DSP equipment and defining key technical and quality parameters for individual equipment and entire systems.
• Establishing the strategy for equipment testing, start‑ups, and qualifications of DSP equipment, and ensuring qualification activities are completed on time and with high quality.
• Driving optimization of DSP processes, integrating operational excellence principles into DSP process and facility design, fostering innovation, and proactively ensuring compliance.
• Participating in strategic activities, projects, and decision‑making processes to ensure state‑of‑the‑art manufacturing and laboratory operations.
• Fostering teamwork, knowledge‑sharing, and applying broad cross‑functional expertise 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.
• Collaborating with MS&T experts in defining the validation strategy.

What you will bring to the role: 

• University degree in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy, or another relevant scientific discipline. A Master's degree or equivalent experience is preferred.
• Minimum 2-5 years of experience in process support roles within manufacturing and/or quality environments.
• Knowledge of pharmaceutical manufacturing processes, GMP requirements, and regulatory expectations.
• Advanced English proficiency and excellent command of Slovenian.
• Experience with downstream processing (DSP) operations or biologics manufacturing is considered an advantage.
• Strong analytical thinking and a structured approach to problem-solving.
• Proactive mindset, self-initiative, and the ability to collaborate effectively within cross-functional teams.

What we offer:

Job location: Ljubljana

Contract type: permanent contract with 6-month probation period

Expected weekly working hours: 40

*Pay range: €45,120 – €67,680 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 August 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

Assembly Language, Change Control, Chemical Engineering, Chemistry, Continual Improvement Process, Efficiency, General Hse Knowledge  , Good Documentation Practice, Knowledge Of Capa, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Process Control, Productivity, Risk Management, Root Cause Analysis (RCA), Scheduler, Six Sigma, Sop (Standard Operating Procedure), Team Work, Technology Transfer, Web Methods Flow