• Vodenje aktivnosti validacije procesov in validacije čiščenja skozi celoten življenjski cikel izdelka.
• Priprava ter pregled načrtov validacije, protokolov in poročil za komercialne proizvodne procese.
• Koordinacija in izvajanje validacijskih aktivnosti v proizvodnem okolju.
• Izvajanje ocen tveganja za zagotavljanje pripravljenosti na validacijo in robustnosti procesov.
• Sodelovanje z ekipami za prenos tehnologije pri uspešnem uvajanju novih izdelkov in prenosih proizvodnje med lokacijami.
• Podpora stalnemu preverjanju procesov ter prepoznavanje priložnosti za neprekinjeno spremljanje delovanja procesov.
• Upravljanje odstopanj, povezanih z validacijo, ter predlaganje učinkovitih korektivnih in preventivnih ukrepov (CAPA).
• Zagotavljanje skladnosti validacijskih aktivnosti z veljavnimi zahtevami dobre proizvodne prakse (GMP) in standardi kakovosti na lokaciji.

• Najmanj pet let delovnih izkušenj na področju biofarmacevtske proizvodnje, tehničnega razvoja ali področja Manufacturing Science & Technology (MS&T).
• Poglobljeno strokovno znanje s področja validacije proizvodnih procesov za proizvodnjo biološke učinkovine v velikem merilu v sesalskih ali mikrobnih proizvodnih sistemih.
• Dokazane izkušnje s pripravo in pregledovanjem validacijske dokumentacije ter tehničnih poročil.
• Dobro poznavanje načel upravljanja tveganj in aktivnosti validacije procesov skozi njihov celoten življenjski cikel.
• Izkušnje s podporo prenosom tehnologije in uvajanjem novih izdelkov v reguliranem okolju.

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.  

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Are you passionate about bringing groundbreaking biopharmaceutical products to patients through robust and compliant manufacturing processes? As a Senior Validation Expert (m/f/d), you will play a pivotal role in ensuring the successful validation and lifecycle management of large-scale manufacturing processes, supporting new product launches, technology transfers, and continuous process verification. Working alongside cross-functional experts, you will help shape validation strategies, drive operational excellence, and contribute directly to delivering high-quality therapies while maintaining the highest standards of compliance, quality, and patient safety.

Your key responsibilities: 

• Lead process and cleaning validation activities across the product lifecycle.
• Author and review validation plans, protocols, and reports for commercial manufacturing processes.
• Coordinate and execute validation activities on the manufacturing floor.
• Drive risk assessments to support validation readiness and process robustness.
• Partner with technology transfer teams to enable successful product introductions and site transfers.
• Support ongoing process verification and identify opportunities for continuous process monitoring.
• Manage validation-related deviations and recommend effective corrective and preventive actions.
• Ensure validation activities comply with current Good Manufacturing Practice requirements and site quality standards.

What you will bring to the role: 

• Minimum five years of experience in biomanufacturing, technical development, or Manufacturing Science and Technology.
• Strong expertise in validating large-scale mammalian or microbial drug substance manufacturing processes.
• Proven experience authoring and reviewing validation documentation and technical reports.
• Solid understanding of risk management principles and process validation lifecycle activities.
• Experience supporting technology transfers and new product introductions in a regulated environment.
• Excellent collaboration, communication, and problem-solving skills within cross-functional teams.

What we offer: 

Job location: Lendava

Contract type: permanent contract with 6-month probation period 

Expected weekly working hours: 40 

*Pay range (annual gross salary): €46,400 – €69,600  

*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 (the maximum annual amount is 3,224.18 EUR). 
• Collective life and accident insurance (24/7 coverage). 
• A hybrid work environment offering flexibility and remote work possibilities

Ready for your next career move? 
You are kindly invited to submit your application in English and Slovene, including a CV, by October 10th 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