Validation Expert for Biopharma

Vaš doprinos k delovnem mestu: 

• Najmanj 4–6 let ustreznih izkušenj na področju bioproizvodnje, tehničnega razvoja, MS&T ali kakovosti, s poudarkom na validaciji proizvodnje učinkovin iz sesalskih ali mikrobnih celic na veliki skali.

• Dokazana strokovnost na področju validacije procesov in čiščenja v obratih za proizvodnjo učinkovin iz sesalskih ali mikrobnih celic na veliki skali.

• Diploma iz farmacije, farmacevtske tehnologije, biokemije, kemijskega inženirstva ali sorodne znanstvene discipline; zaželena je magistrska stopnja ali enakovredna izobrazba.

• Razumevanje regulatornih zahtev, validacije procesov, stalnega preverjanja procesov in cGMP.

• Dobre komunikacijske in predstavitvene veščine.

• Sposobnost samostojnega dela in učinkovitega upravljanja časa.

• Dobro znanje angleškega jezika (ustno in pisno), znanje lokalnega jezika je prednost.

Kaj nudimo:

Lokacija dela: Lendava, Slovenija

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

Predvideni tedenski delovni čas: 40 ur

Plačni razpon: *31.840 - 47.760 EUR bruto, letno

Plača pri Sandozu temelji glede na ravni delovnega mesta, kvalifikacijah, specifičnih znanjih, delovnih izkušnjah. Visoko usposobljeni kandidati so običajno umeščeni okoli tržnega medianega izhodišča, manj izkušeni nižje na razponu, tisti z močnimi ali nišnimi kompetencami pa višje. Pri določanju položaja v razponuupoštevamo tudi notranjo uravnoteženost plač in zunanje tržne podatke*.

Kaj še vključuje naš kompenzacijski paket:

• Letna nagrada (kratkoročna spodbuda – STI): odstotek letne plače

• Regres za 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

• Dodatek za izmensko delo (15 %); večizmensko 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 prilagodljivost in možnost dela na daljavo. – če to velja za zadevno delovno mesto

Ste pripravljeni na naslednji korak v karieri?
Prijavo z življenjepisom v angleškem jeziku lahko oddate najpozneje do 25. maja 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

______________________________________________________________________________

For the new large scale Biopharmaceuticals DS production facility at Lek in Lendava, we are currently seeking Validation Experts with experience in Upstream and / or Downstream Bioprocessing.

Join us as a Validation Expert and be the key to ensuring our biopharmaceutical products meet the highest quality standards. You'll lead crucial validation projects for bioprocesses, keeping us compliant with global regulations and driving continuous improvement. If you're passionate about precision and quality, and want to make a real impact, we want you on our team.

Join us as a Founder of our ‘new’ Sandoz and Lek!

Your key responsibilities:

• Author and review process, and cleaning validation plans, protocols & reports, for initial validation and/or ongoing process verification (OPV).

• Participate in pre-validation activities and risk assessments to ensure the success of commercial process validation and lead the execution of validation activities on the shop floor.

• Participate in the Tech Transfer teams, under project leadership of the Tech Transfer leads, as core member for process validation.

• Work in close collaboration with the sending site (development organization or production facility) for new product launches and site to site technical transfers ensuring that knowledge is transferred, control strategies are appropriate, risks are analysed and controlled and commercial processes are validation ready.

• Actively participate in defining and implementing the validation strategy for production and cleaning process, for both for initial validation and Ongoing Process or Cleaning verification (OPC, OCV) as well as advocacy to the relevant authorities.

• Support Product Stewards in maintaining the process control strategy. Translate applicable process parameters and the process control strategy into a focused validation plan for process validation.

• Support process validation lifecycle activities by ensuring a state of control is maintained through ongoing process verification (OPV). Ensure that appropriate variables are identified for on-going monitoring.

• Support validation lead for KPI reporting.

• Ensure that all Site validation activities are performed and are in line with requirements and cGMP, manage deviations associated with process validation and makes recommendations for deviation resolution as well as prevention of reoccurrence.

What you will bring to the role:

• Minimum 4-6 years of relevant experience in biomanufacturing, technical development, MS&T or Quality, with a focus on validation of large scale mammalian or microbial drug substance manufacturing.

• Proven expertise with Process and Cleaning validation in large scale mammalian or microbial Drug substance production facilities.

• BSc. in Pharmacy, Pharmaceutical Technology, Biochemistry, Chemical Engineering, or a related scientific discipline. MSc or equivalent is preferred.

• Understanding of regulatory requirements, process validation, continued process verification, and cGMP.

• Good communication and presentation skills.

• Ability to work independently and manage time effectively.

• Good knowledge of English, both in speaking and writing.

• Knowledge of the local language is a plus.

What we offer:

Job location: Lendava, Slovenia

Contract type: permanent contract with 6-month probation period

Expected weekly working hours: 40

Pay range: ***€31.840,00 - €47.760,00 gross per year**

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

• 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, including a CV, by May 25th, 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