Validation Lead at Biopharmaceuticals

Job Description Summary

Job Description

As Validation Lead at the biomanufacturing site in Lendava, you will be responsible for developing, implementing and managing the site process validation, primary packaging validation, cleaning validation and revalidation strategies to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities' expectations.

Join us as a Founder of our 'new' Sandoz and Lek

Your key responsibilities:

Your responsibilities include, but not limited to:

• Defining and implementing the validation strategy (process, cleaning, media status times, SIPs, product transport, periodic validation checks) and advocacy to the relevant authorities.
• Overall responsibility for establishing, prioritizing, implementing and tracking the validation master plan for process validation, cleaning, packaging, validation of media/medium residence times and chromatography media use cycles, and periodic process validation verification (OPV), periodic check of cleaning validation statuses.
• Ensuring that all production and purification processes and other supporting processes are validated and that a validation status review is maintained on site.
• Preparation of more complex validation protocols, participation and review of the preparation of all validation documentation.
• Ensuring that all validation activities are carried out on site and that they comply with applicable Sandoz requirements and current GMP guidelines and regulatory requirements, addressing deviations related to these activities, including oversight of validation preparations and validation resulting from technical changes.
• You are the host of the validation team.
• In collaboration with Engineering, IT, QC, AS&T units, identify contact persons for equipment/infrastructure qualification, systems qualification, media, analytical methods validation.
• Participation in the provision of process data obtained during validation to be used for the preparation of registration dossiers.
• Representing the site in global validation teams.

What you will bring to the role:

• Bachelor's degree in chemistry, pharmacy, chemical engineering or pharmaceutical technology. PhD in the above or other relevant fields desirable.
• Active knowledge of English.
• Knowledge of Microsoft Office tools.
• Minimum 5 years' experience in manufacturing/production science and technology/technical development/quality in bio processes.
• Proven experience leading validation projects and teams.
• Ability to work effectively in a cross-functional environment.
• Strong problem-solving and analytical skills.
• Strong English communication skills required; familiarity with the local language is a plus.

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.

Possible job locations: Lendava (Slovenia)

We offer a permanent contract with a 6-month probation period. You are kindly invited to submit your application in English language, including your CV, by November 30th, 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 Vodja validacij na bioproizvodni lokaciji v Lendavi boste odgovorni za razvoj, implementacijo in opravljanje procesnih validacij, validacij primarnega pakiranja, validacij čiščenja in revalidacij, skladno s časovnimi roki ter razpoložljivimi sredstvi.

Vaše ključne odgovornosti:

• Opredeljevanje in izvajanje validacijske strategije (proces, čiščenje, časi stanja medijev, SIP, transport produktov, periodična preverjanje validacij) in zagovarjanja pred ustreznimi organi.
• Splošna odgovornost za vzpostavitev, določanje prioritet, izvajanje in sledenje glavnega načrta validacije za validacijo procesov, čiščenja, pakiranja,  validacije zadrževalnih časov medijev/gojišč in ciklov uporabe kromatografskih nosilcev ter periodično preverjanje validiranosti procesov (OPV), periodično preverjanje statusov validacije čiščenja.
• Skrb za to, da so vsi proizvodni in čistilni procesi ter ostali podporni procesi validirani ter da se na lokaciji vodi pregled validacijskega statusa.
• Pripravljanje zahtevnejše validacijske protokole, sodelovanje in pregled priprave celotne validacijske dokumentacije.
• Skrb za izvedbo vseh validacijskih aktivnosti na lokaciji in za njihovo skladnost z veljavnimi zahtevami Sandoza in trenutno veljavnimi GMP smernicami ter regulatornimi zahtevami, obravnava odstope v zvezi s temi aktivnostmi, vključno z nadzorom nad pripravami na validacijo in validacijo, ki izhaja iz tehničnih sprememb.
• Ste gostitelj tima za validacije.
• V sodelovanju z enotami Inženiring, IT, QC, AS&T določanje kontaktnih oseb za kvalifikacijo opreme / infrastrukture, kvalifikacijo sistemov, medijev, validacijo analitskih metod.
• Sodelovanje pri zagotavljanju procesnih podatkov, pridobljenih med validacijo, ki se bodo uporabile za pripravo registracijske dokumentacije.
• Zastopanje lokacije v globalnih timih za validacije.

Vaš doprinos k delovnem mestu: 

• Univerzitetna diploma iz kemije, farmacije, kemijskega inženiringa ali farmacevtske tehnologije. Zaželen doktorat iz navedenih smeri ali drugih ustreznih smeri.
• Minimalno 5 let izkušenj v bio proizvodnji / proizvodni znanosti in tehnologiji / tehničnem razvoju / kakovosti.
• Dokazljive izkušnje z vodenjem validacijskih projektov in timov.
• Sposobnost učinkovitega dela v medfunkcijskem okolju.
• Izrazite veščine reševanja problemov in analitične sposobnosti.
• Aktivno znanje angleškega jezika; poznavanje lokalnega jezika je prednost.

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: Slovenija (Lendava) 

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