Process Specialist I

Job Description
Sandoz, of which Lek is also a part, is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz and Lek associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

We are looking for a
Process Specialist
to join one of the fastest-growing sectors in the pharmaceutical industry – the production of biosimilar medicines. We are seeking motivated and detail-oriented process technicians who will become a key part of our manufacturing operations.

This is your opportunity to directly contribute to the development and production of high-quality biological medicines that will be accessible to a wide range of patients and help save and improve lives.

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

Your Key Responsibilities
Your responsibilities include, but not limited to:

• Managing and participating in manufacturing processes. Performing and monitoring all assigned activities in accordance with the production plan and applicable GMP standards, work instructions, operational, environmental, and safety guidelines.
• Applying and enforcing current Good Manufacturing Practice (GMP) standards and consistently documenting activities in compliance with GMP regulations. Responsible for timely and accurate review and documentation of batch records.
• Proper and timely execution of cleaning, preparation, and sterilization (as needed) of production equipment and manufacturing areas, and responsibility for maintaining production areas (cleaning, organizing, 5S, etc.).
• Daily inspection of production equipment, support devices, and facilities to ensure and monitor proper functioning, aiming to detect early signs of irregularities. Responsible for minor maintenance tasks and repairs in production facilities.
• Sampling, dividing, and distributing samples, and performing in-process controls. Carrying out IPC-related activities in LIMS or ERP systems or other relevant platforms. Executing ERP business process transactions related to production.
• Proper handling of biological and chemical substances in the manufacturing area. Managing consumable inventory as needed.
• Identifying and reporting deviations and irregularities in production. Investigating and participating in deviation investigations, OOS, OOE, etc., and contributing to deviation resolution. Responsible for proposing corrective and preventive actions (CAPA) in case of deviations.
• Sharing knowledge with colleagues and conducting on-the-job training (OJT) for relevant team members when needed. Participating in all training and education required for this position.

What You Will Bring To The Role

• Minimum of 3 years of work experience in similar roles; candidates with experience in biological drug substance manufacturing will be given preference.
• Secondary education in chemistry, mechanical engineering, technical fields, pharmacy, or other relevant disciplines.
• Basic knowledge of English.
• Familiarity with Microsoft Office tools.

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
temporary contract with 6-month of probation period
. You are kindly invited to submit your application in English language, including CV, by
30

Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. In delivering over 900 million treatments with Sandoz medicines to patients around the world, 20,000 people of more than 100 nationalities are involved. 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, 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, katerega del je tudi Lek, je trenutno kot pionir in vodilni svetovni ponudnik trajnostnih generičnih in podobnih bioloških zdravil v vznemirljivem in preobrazbenem obdobju.

Kot samostojno podjetje, ki kotira na borzi, Sandoz zdaj stremi k še večji strateški osredotočenosti, agilnosti, jasnejšim poslovnim ciljem, večji donosnosti za delničarje in krepitvi svoje kulture za vse nas, sodelavce in sodelavke v Sandozu in Leku. To je vznemirljivo obdobje v naši zgodovini, ki nam bo vsem z ustvarjanjem nove in ambiciozne poti, nudila edinstveno priložnostna poklicnem in osebnem področju.

Iščemo
Tehnika
za delo v eni najhitreje rastočih panog farmacije – proizvodnji podobnih bioloških zdravil (biosimilarji). Iščemo motivirane in natančne procesne tehnike, ki bodo postali ključni del našega proizvodnega procesa. Ponujamo ti priložnost da s svojim delom neposredno prispevaš k razvoju in proizvodnji visokokakovostnih bioloških zdravil, ki bodo dostopna širokemu krogu bolnikov in bodo reševala in izboljševala življenja.

Pridružite se nam pri soustvarjanju "novega" Sandoza in Leka

Vaše Ključne Odgovornosti

• Upravljanje in sodelovanje pri proizvodnih procesih. Izvajanje in nadzorovanje vseh dodeljenih dejavnosti v skladu s proizvodnim načrtom in veljavnimi GMP-ji, delovnimi, obratovalnimi, okoljskimi in varnostnimi navodili ter smernicami.
• Uporabljanje in uveljavljanje aktualnih pravil dobre proizvodne prakse (GMP) ter dosledno dokumentiranje aktivnosti v skladu s predpisi dobre proizvodne prakse (GMP). Odgovornost za pravočasno in točno pregledovanje in dokumentiranje evidenc o serijah.
• Pravilno in pravočasno izvajanje čiščenj, priprave in sterilizacije (po potrebi) proizvodne opreme in proizvodnih prostorov ter odgovornost za vzdrževanje proizvodnih površin (čiščenje, urejanje, 5S, ...).
• Vsakodnevno pregledovanje proizvodne opreme, podpornih naprav in prostorov z namenom zagotavljanja in spremljanja pravilnega delovanja opreme s ciljem odkrivanja zgodnjih znakov nepravilnosti. Odgovornost za manjša vzdrževalna dela in popravila v proizvodnih obratih.
• Vzorčenje, razdeljevanje, distribuiranje vzorcev in izvajanje medprocesnih kontrol. Izvajanje dejavnosti, ki so povezane z IPC v sistemu LIMS ali ERP ali v drugih ustreznih sistemih. Izvajanje transakcij oz. dejavnosti poslovnega procesa ERP, ki so povezane s proizvodnjo.
• Pravilno ravnanje z biološkimi in kemičnimi snovmi v proizvodnem obratu. Po potrebi upravljanje z zalogami potrošnega materiala.
• Identificiranje in poročanje o odstopih in nepravilnosih v proizvodnji. Raziskovanje in sodelovanje pri raziskavah odstopov, OOS, OOE itd. ter pri reševanju odstopov. Odgovornost za predlaganje korektivnih in preventivnih ukrepov (CAPA) v primeru odstopov.
• Prenašanje znanja na sodelavce in po potrebi izvajanje usposabljanja za delo (OJT) za relevantne sodelavce. Udeležba na vseh usposabljanjih oz. izobraževanjih, ki so zahtevana za to delovno mesto.

Vaš Doprinos k Delovnem Mestu

• Minimalno 3 leta delovnih izkušenj na primerljivih delovnih mestih, prednost imajo kandidati z izkušnjami s področja proizvodnje bioloških učinkovin
• Srednješolska stopnja izobrazbe kemijske, strojne, tehnične, farmacevtske ali druge ustrezne smeri
• Osnovno znanje angleškega jezika
• Poznavanje orodja Microsoft Office

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
*.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 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.