Process Expert I

Job Description Summary

Job Description

As announced in December 2023, we started construction of one of the largest Biotech Large Scale production centers in Europe, located at Lendava, Slovenia. Operations will start in late 2026.

Become part of this great story and team, excellent opportunity to contribute to the success of the project with your knowledge and experiences

As Process Expert you will be responsible for providing advanced technical support for the production of biological active substances (Bioprocess), mastering and optimizing complex production processes, and managing advanced process technologies and products. This also includes participating in continuous quality and productivity improvement, in accordance with current GMP, SOPs, and applicable guidelines and functional standards (e.g. HSE), as well as supporting the smooth operation of production with the goal of improving quality and compliance.

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

Your key responsibilities:

Your responsibilities include, but not limited to:

• Provide front line expert support for most complex issues and challenges, related to processes and production of biosimilars, ensure on time shop floor support

• Act as Subject Matter Expert (SME) for specific techniques, products or technical processes during the production of biosimilars

• Coordinate and ensure the completion of all production operations on time, in accordance with the documentation and in compliance with GMP

• Ensure timely treatment of deviations, complaints, escalations, OOE, OOS, and the implementation of effective CAPAs within agreed timelines.

• Monitor the most complex processes, identify possible trends and ensure timely interventions in the event of observed negative trends

• Ensure that all of the most complex production documents, project timelines and/or validations are systematically and timely up to date for the need of regular production, in compliance with GMP

• Transfer of information and increase awareness of production teams following problems or modifications having a technical, quality or HSE impact

• If nominated, carry out trainings, including delivering state-of-the-art solutions and new scientific findings

What you will bring to the role:

• BSc./MSc degree in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy
  or equivalent scientific degree.

• Desirable MSc. or equivalent experience of the production of biosimilars

• Fluent in English and proficient in site local language

• Knowledge of Microsoft Office

• Minimum 5 year experience in process support role on the shop floor of
  manufacturing and/or quality.

• Process understanding (Pharma biosimilars, GMP, Regulatory aspects).

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: Slovenia (Lendava) 

We offer permanent contract with 6-month of probation period. You are kindly invited to submit your application in English language, including CV, by 30.11.2025.

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. 

#Sandoz

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Kot smo napovedali decembra 2023, smo začeli z gradnjo enega največjih centrov za veliko proizvodnjo biotehnoloških izdelkov v Evropi, ki se nahaja v Lendavi, Slovenija. Obrat bo začel delovati konec leta 2026.

Postanite del te izjemne zgodbe in ekipe – odlična priložnost, da s svojim znanjem in izkušnjami prispevate k uspehu projekta

Kot Tehnolog proizvodnih procesov boste odgovorni za zagotavljanje napredne tehnične podpore pri proizvodnji biološko aktivnih učinkovin (bioproces), obvladovanje in optimizacijo kompleksnih proizvodnih procesov ter upravljanje naprednih procesnih tehnologij in izdelkov. Vaše naloge bodo vključevale tudi sodelovanje pri nenehnem izboljševanju kakovosti in produktivnosti v skladu z veljavnimi smernicami GMP, internimi postopki (SOP) ter drugimi relevantnimi standardi in smernicami (npr. ZVO), kot tudi podporo nemotenemu delovanju proizvodnje z namenom izboljšanja kakovosti in skladnosti.

Pridružite se nam pri soustvarjanju "novega" Sandoza in Leka

Vaše ključne odgovornosti:

• Zagotavljanje strokovne podpore za kompleksna vprašanja in izzive, povezane s procesi in proizvodnjo podobnih bioloških zdravil in zagotavljanje pravočasne podpore na proizvodnem področju

• Opravljanje vloge strokovnjaka na svojem področju (SME) za specifične tehnike, izdelke ali tehnološke procese

• Usklajevanje in zagotavljanje pravočasnega dokončanja vseh proizvodnih postopkov v skladu z dokumentacijo in GMP

• Zagotavljanje pravočasne obravnave odstopov, reklamacij, eskalacij, rezultatov OOE, OOS in izvajanje učinkovitih korektivnih ter preventivnih ukrepov (CAPA) v dogovorjenih rokih.

• Spremljanje kompleksnih procesov in ugotavljanje morebitnih trendov ter pravočasno ukrepanje ob opaženih negativnih trendih

• Zagotavljanje sistematičnega ter pravočasnega posodabljanja kompleksne proizvodne dokumentacije za potrebe redne proizvodnje, projektnih časovnic in/ali validacij skladno z zahtevami GMP

• V sodelovanju z ZVO prispevanje k nadgradnjam in izboljšavam na področju ZVO s preverjanjem praktične uporabe v timu

• Po potrebi izvajanje usposabljanj, vključno z predstavljanjem najsodobnejših rešitev in novih znanstvenih dognanj

Vaš doprinos k delovnem mestu: 

• Diploma (VS) ali magisterij (MAG) s področja inženirstva, farmacevtske tehnologije, kemije, farmacije ali druge ustrezne znanstvene smeri

• Zaželen magisterij ali enakovredne izkušnje s proizvodnjo podobnih bioloških zdravil (biosimilarji)

• Tekoče znanje angleškega jezika in dobro znanje lokalnega jezika

• Poznavanje orodja Microsoft Office

• Najmanj 5 let izkušenj v vlogi podpore proizvodnim procesom na proizvodnem področju in/ali v kakovosti

• Razumevanje proizvodnih procesov (biosimilarji, GMP, regulativa)

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: Slovenia (Lendava) 

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

Prijave z življenjepisom v angleškem in slovenskem jeziku lahko oddate najkasneje do 30.11.2025 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.  

#Sandoz

Skills Desired