Validation Expert for Biopharma

Job Description Summary

Job Description

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:

Your responsibilities include, but not limited to:

• Support Product Steward in maintaining the process control strategy. Translate applicable process parameters and the process control strategy into a focused validation plan for process validation.
• Support site validation planning by writing and maintaining master plans for processes, cleaning, packaging processes and ongoing verification for processes and cleaning (as applicable).
• 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.
• Author and review process, packaging or cleaning validation protocols & reports, ongoing process and cleaning verification protocols & reports.
• 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.
• Work in close collaboration with development organization (or sending site) for technical transfers and new product launches to ensure that knowledge is transferred, control strategies are appropriate, risks are analyzed and controlled and to ensure that commercial processes are validation ready.
• Participate in pre-validation activities and risk assessments to ensure the success of commercial process validation and support the execution of validation activities on the shop floor.

What you will bring to the role:

• BSc. in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical
• Technology.
• Minimum 2-3 years experience in BIO manufacturing/ manufacturing science and technology/technical development/quality.
• Functional knowledge of English.
• Strong analytical and problem-solving abilities.
• Excellent communication and teamwork skills.
• Meticulous attention to detail and organizational skills.
• Ability to work independently and manage time effectively.
• Proactive and adaptable mindset.

You'll receive:

Employment at the most reputable employer in Slovenia offers Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical, mental and social well-being (Energized for Life), Unlimited learning and development opportunities.

Job location: Lendava, Slovenia

We offer a permanent contract with a 6-month probation period. You are kindly invited to submit your application in English, including your CV, by November 30st, 2025.

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.

#BIORampUp #Sandoz

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Kot Ekspert validacij boste ključni člen pri zagotavljanju, da naši biofarmacevtski izdelki dosegajo najvišje standarde kakovosti. Vodili boste ključne validacijske projekte za bioprocese, zagotavljali skladnost z globalnimi predpisi in spodbujali nenehne izboljšave. Če cenite natančnost in kakovost ter želite prispevati k pomembnim dosežkom, potem ste prava oseba za našo ekipo

Vaše ključne odgovornosti:

• Podpirati skrbnika izdelkov pri vzdrževanju strategije kontrole procesov. Parametre veljavnih procesov in strategijo kontrole procesov pretvarjati v jasen načrt validacije procesov.
• Podpirati načrtovanje validacije na lokacijah s pripravo in vzdrževanjem okvirnih načrtov za procese, čiščenje, pakiranje procesov in tekoče preverjanje procesov in čiščenja (po potrebi).
• Podpirati aktivnosti za upravljanje življenjskega cikla validacije procesov z vzdrževanjem stanja nadzora s tekočim preverjanjem procesov. Skrbeti za opredelitev ustreznih spremenljivk za tekoče spremljanje.
• Pripravljati in pregledovati protokole in poročila za validacijo procesov, pakiranja ali čiščenja, vključno s protokoli in poročili za tekoče preverjanje procesov in čiščenja.
• Nuditi podporo vodji validacij pri poročanju o ključnih kazalnikih uspešnosti (KPI).
• Zagotavljati, da se na lokaciji izvedejo vse validacijske aktivnosti in da so izvedene v skladu z zahtevami in cGMP-jem, ter upravljati odstopanja pri validaciji procesov in dajati priporočila za njihovo reševanje ter preprečevanje ponovitev.
• Biti v tesnem sodelovanju z razvojnimi organizacijami (ali izvorno lokacijo) za tehnične prenose in lansiranje novih izdelkov skrbeti za prenos znanja, primernost strategij kontrole, analizo in obvladovanje tveganj ter zagotavljati, da so komercialni procesi pripravljeni za validacijo.
• Sodelovati pri pred-validacijskih aktivnostih in ocenjevanju tveganj za zagotovitev uspešnosti validacije komercialnih procesov in podpirati izvedbo validacijskih aktivnosti na delovni površini.

Vaš doprinos k delovnem mestu: 

• Univerzitetna diploma kemijske ali farmacevtske smeri, kemijskega inženiringa ali farmacevtske tehnologije.
• Aktivno znanje angleškega jezika.
• Minimalno 2-3 leta izkušenj na področju BIO proizvodnje / proizvodne znanosti in tehnologije / tehničnega razvoja / kakovosti.
• Izrazite analitične sposobnosti in spretnost reševanja problemov.
• Odlične komunikacijske in timske veščine.
• Doslednost, natančnost ter izrazite organizacijske spretnosti.
• Sposobnost samostojnega dela in učinkovito upravljanje s časom.
• Proaktivnost in prilagodljivost.

Kaj nudimo:

Zaposlitev pri najuglednejšem delodajalcu v Sloveniji vam prinaša konkurenčen plačni paket, letni bonus, fleksibilen način dela z možnostjo prilagajanja urnika in delom od doma, pokojninsko shemo, shemo nagrajevanja in priznanja dosežkov, razširjeni program promocije zdravja na področju telesnega, duševnega in družbenega počutja (Polni življenja) ter dogodke, neomejene priložnosti za učenje in razvoj. 

Možne lokacije dela: Lendava, Slovenija

Z izbranim kandidatom bomo sklenili delovno razmerje nedoločen čas s poskusno dobo 6 mesecev. 

Prijave z življenjepisom v angleškem in slovenskem jeziku lahko oddate najkasneje do 30. novembra 2025 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.  

#BioRampUp #Sandoz

Skills Desired