Salary Range:
€27,160.00 - €50,440.00
Job Description Summary
V Novartis Slovenija uporabljamo inovativne znanstvene pristope in tehnologije za reševanje nekaterih najzahtevnejših zdravstvenih vprašanj v družbi. Odkrivamo in razvijamo prelomne terapije za zdravljenje bolezni, za katere je še vedno veliko neizpolnjenih potreb po zdravljenju.
Iščemo navdušene in usposobljene strokovnjake, ki bi se pridružili naši proizvodni ekipi v Klinični proizvodnji (Cx) Mengeš, ki je namenjena pospeševanju odkrivanja zdravil za paciente po vsem svetu. Kot ekspert za oskrbo zdravil boste del ekipe Kliničnih Proizvodnih Operacij (Cx MO).
Kot del naše ekipe boste primarno odgovorni za izvajanje dejavnosti, ki podpirajo proizvodni proces, kot so obvladovanje in nadzor pogojev okolja (čistih prostorov), podpora menjavi izdelkov in zagotavljanje skladnosti procesov s predpisi ter notranjimi postopki podjetja in zahtevami GxP.
Postanite del dinamične ekipe, ki na novo opredeljuje zdravljenje in prinaša upanje tistim, ki ga najbolj potrebujejo. Pridružite se nam pri oblikovanju prihodnosti varovanja zdravja in pri ustvarjanju pomembnih razlik v življenju bolnikov po vsem svetu. Veselimo se vašega prihoda v naš tim!
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In Novartis Slovenia we use innovative science and technology to address some of society’s most challenging healthcare issues. We discover and develop breakthrough treatments, to treat diseases for which there is still a high unmet treatment need.
We are looking for enthusiastic and skilled professionals to join our manufacturing team at Clinical Manufacturing (Cx) Mengeš, dedicated to accelerating drug discovery for patients around the world. As an Expert Drug Supply, you will be part of the Clinical Manufacturing Operations (Cx MO) team.
As part of our team, you will be primarily responsible for executing activities that support the manufacturing process, like environmental monitoring (cleanrooms), product change-over and ensuring compliance of processes with regulations as well as company internal procedures and GxP requirements.
Be part of a dynamic team that is reimagining medicine and delivering hope to those who need it most. Join us in shaping the future of healthcare and making a meaningful difference in the lives of patients worldwide. We look forward to welcoming you to our team!
Location: Menges, Slovenia
#LI-Hybrid
Job Description
Ključne odgovornosti
- Ustvarjanje učinkovitih in široko segajočih postopkov ter spodbujanje njihove uvedbe.
- Gradnja in vzdrževanje močne mreže znotraj in zunaj organizacije za pridobivanje znanja, najboljših praks, izkušenj in ustvarjanje sinergij. Prepoznavanje težavnih in konfliktnih situacij, komuniciranje z vključenimi partnerji ali strankami ter empatično prispevanje k rešitvam.
- Vodenje upravljanja sprememb – Komuniciranje, naslavljanje in reševanje ključnih izzivov (npr. odstopanja in nepričakovani rezultati) ter drugih ključnih tem znotraj lastnega področja odgovornosti. Vodenje prenosa znanja ali postopkov drugim oddelkom ali zunanjim izvajalcem, vključno z odpravljanjem težav in usposabljanjem na terenu. Zagotavljanje izmenjave najboljših praks in znanja, medsebojna podpora v timu in širše ter zastopanje ekipe na ustreznih mestih.
- Podpiranje razvoja kulture v procesno usmerjeno organizacijo; vzor odgovornega, vključujočega, uspešnega delovanja, spoštovanja različnosti, zaupanja in nenehnega izboljševanja.
- Sodelovanje z zdravstvenimi organi, kjer je to primerno; delovanje kot tehnični strokovnjak na presojah s pomembnim prispevkom k notranjim (npr. GGA) in zunanjim presojam (npr. JAZMP).
- Samostojno načrtovanje, organizacija, izvajanje, nadzor, spremljanje in dokumentiranje dejavnosti Cx MO (vzorčenje čistih medijev, spremljanje pogojev okolja, čiščenje, certificiranje osebja, pretoka osebja in materialov, pregled dokumentacije, itd.). Izvajanje več dejavnosti hkrati z razumevanjem in izpolnjevanjem potreb strank ter zagotavljanjem, da so vse lastne in timske dejavnosti usklajene s celotnim proizvodnim procesom.
- Priprava, izdajanje, izpolnjevanje in arhiviranje dokumentacije (dnevniki, obrazci, dokumentacija proizvodnih serij, itd.). Pregled in preverjanje podatkov, ki so jih pripravili drugi.
- Predlog in vpeljava izboljšav, novih metod, tehnologij ali drugih procesov za izboljšanje. Zagotavljanje ustreznega znanja za njihovo implementacijo in vzdrževanje.
- Strokovno in tehnično svetovanje, iskanje informacij, spodbujanje izmenjave znanja med zaposlenimi. Opravljanje kompleksnih nalog v GxP okolju.
- Druge naloge določene med letnim postopkom postavljanja ciljev in s kazalniki uspešnosti.
Vaš doprinos k delovnem mestu
- Visokošolska ali druga ustrezna stopnja izobrazbe iz farmacije, biokemije, biotehnologije, kemije, mikrobiologije ali druge ustrezne smeri.
- Najmanj 3 leta neposredno povezanih delovnih izkušenj kot strokovnjak v proizvodnji bioloških zdravil.
- Tekoče znanje slovenščine. Tehnično znanje angleščine.
- Ustrezno poznavanje programske opreme in računalniških orodij (npr. Microsoft Office).
- Poznavanje GxP ter dodeljenega Cx MO okolja (čisti prostori, osebni in materialni tokovi, itd.)
Želene izkušnje
- Poznavanje reševanja GxP odstopov in upravljanje GxP sprememb.
- Izkušnje z zagovori na internih in/ali zunanjih presojah.
Z izbranim kandidatom / kandidatko bomo sklenili delovno razmerje za nedoločen čas s poskusno dobo 6 mesecev. Prosimo, da oddate prijavo z življenjepisom v slovenskem in angleškem jeziku.
Key Responsibilities
- Generating impactful and wide-reaching procedures and driving their implementation.
- Building and sustaining strong network in- and out-side the organization for knowledge gain, best practice, lessons learned, and synergies. Identifying issues and conflict situations, communicating to involved partners or customers and contributing with empathy to solutions.
- Driving change management - Communicating, addressing and solving key challenges (e.g. deviations and unexpected results) and other critical topics within own area of responsibility; communicating effectively across organizational interfaces. Leading the transfer of know-how or procedures to other departments or external contractors, including troubleshooting and on-site training. Ensuring best practice sharing, knowledge exchange, and cross-functional support within the team and with other organizations and representing the team in corresponding meetings as needed.
- Supporting cultural evolution to a process-oriented organization. Role modelling a culture of accountability, diversity and inclusion, trust, high performance as well as continuous improvement.
- Interacting with health authorities where appropriate; acting as technical expert in audits and significantly contributing to internal (e.g. GGA) and external audits (e.g. JAZMP).
- Independently designing, planning, organizing, performing, supervising, monitoring and documenting Cx MO activities (sampling of clean utilities, environmental monitoring, cleaning, certification of personnel, personnel and material flows, review of documentation, etc.). Handling several activities at a time by understanding and meeting customer needs and ensuring all own and team activities are aligned with overall manufacturing process.
- Preparing, issuing, filling in and archiving documentation (logs, forms, batches records, etc.). Reviewing and verifying data prepared by others.
- Proposing and implementing ideas, new methods, technologies or processes for continuous improvements.
- Providing scientific and technical guidance; performing information searches; actively fostering knowledge exchange within peer population. Performing complex tasks within GxP setup.
- Other tasks as determined during the annual objectives setting process and by KPIs.
Essential Requirements:
- Bachelor’s degree or equivalent in Pharmacy, Bichemistry, Biotechnology, Chemistry, Microbiology or equivalent.
- Minimum 3 years of directly related experience as expert in biologics manufacturing.
- Fluent in Slovene. Technical knowledge of English.
- Adequate knowledge of software and computer tools (e.g. Microsoft Office).
- Knowledge of GxP and the assigned Cx MO environment (cleanrooms, personal and material flows, etc.)
Desirable Requirements:
- Knowledge of GxP deviation handling and managing of GxP changes.
- Experience in defending internal and/or external audits.
We offer permanent employment with 6 months of probation to the selected candidate. Please submit your application with the CV in Slovenian and English language.
Nagrajevanje:
V Novartisu smo zavezani k soustvarjanju prihodnosti medicine ter priznavanju in nagrajevanju ljudi, ki to omogočajo.
Pričakovani letni osnovni razpon plače za delovno mesto:
- Slovenija: €27,160 – 50,440
Osnovna plača se določa na podlagi vnaprej opredeljenih in transparentnih kriterijev, kot so relevantne veščine, kompetence in izkušnje, ne glede na spol, ter v skladu z Novartisovo politiko določanja plač. Po zaposlitvi v Novartisu se plača periodično pregleda v skladu z internimi akti in postopki.
Plačna enakost je temeljno načelo naše kadrovske politike in odraža našo zavezo k ustvarjanju raznolikega, pravičnega in vključujočega okolja, ki vse zaposlene obravnava dostojanstveno in spoštljivo, kot je opredeljeno v našem Kodeksu etike.
Poleg osnovne letne bruto plače so zaposleni upravičeni tudi do spodaj navedenih ugodnosti:
- Letni bonus, ki pripada vsakemu zaposlenemu: 12% letne plače.
- Regres za dopust: Leta 2025 je znašal 2.496 € (neto). Za leto 2026 znaša 2.678,28 € (neto).
- Nagrada za poslovno uspešnost: Leta 2025 je znašala 2.538,64 € (bruto), skupaj z zimskim regresom.
- Prostovoljno dodatno pokojninsko zavarovanje: Novartis v Sloveniji zagotavlja prostovoljno dodatno pokojninsko zavarovanje (5,844 % bruto izplačila, letno omejeno na 3.224,18 €).
Dodatno nezgodno zavarovanje: V času zaposlitve pri Novartisu je zaposleni 24/7 zavarovan za primer smrti ali invalidnosti, ki bi bila posledica nezgode.
Zavarovanje – Specialisti: Kolektivno zdravstveno zavarovanje, ki omogoča hitrejši dostop do specialističnih zdravstvenih storitev pri Zavarovalnici Triglav d.d. za vas in vaše družinske člane.
- Care Connect: Program, ki ponuja zaupno, osebno podporo za vaše duševno zdravje in dobro počutje s pomočjo terapij, svetovanj, orodij in še mnogo več.
- Ostale ugodnosti v skladu z zakonom in kolektivno pogodbo: Prevoz, prehrana ter ostali dodatki.
Preberite brošuro in izvedite več o našem sistemu nagrajevanja: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
Opomba: Ugodnosti se lahko razlikujejo glede na državo ter so skladni z lokalno zakonodajo, vključno z določili kolektivnih pogodb. Celovit pregled vašega paketa prejemkov, vključno z morebitnimi relevantnimi določbami kolektivne pogodbe, ki veljajo za vašo delovno mesto glede na lokacijo zaposlitve in delodajalca Novartis, vam bo posredovan v okviru nadaljnjih korakov zaposlitvenega postopka.
Predani smo raznolikosti in vključenosti: Novartis si prizadeva ustvariti izjemno, vključujoče delovno okolje in oblikovanje raznolikih timov, saj ti predstavljajo naše bolnike in skupnosti, ki jih oskrbujemo.
Zakaj Novartis: Pomagati bolnikom in njihovim družinam zahteva več kot le inovativno znanost. Potrebna je skupnost zavzetih ljudi, kot ste vi. V Novartisu cenimo sodelovanje, podporo in navdihovanje drug drugega za razvoj prebojnih terapij, ki spreminjajo življenja pacientov. Ste pripravljeni ustvariti svetlejšo prihodnost skupaj z nami? https://www.novartis.com/about/strategy/people-and-culture
Rewards:
At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.
Expected Annual Base Salary Range for role:
- Slovenia: €27,160 – 50,440
The salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.
Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.
In addition to your base salary, you will be eligible for benefits listed below:
- Annual bonus for all employees: 12% of annual base salary.
- Holiday allowance: In 2025 it amounted to €2,496 (net). For 2026 it amounts to €2,678.28 (net).
- Yearly performance-based bonus: In 2025 it amounted to €2,538.64 (gross), including the winter allowance.
- Voluntary supplementary pension insurance: Novartis in Slovenia provides voluntary supplementary pension insurance (5.844% of gross salary, capped annually at €3.224,18).
- Shift allowances: shift work (15%); multi-shift work (20%); night work (70%); work on Sundays and public holidays (50%). (if selected candidates will work in shifts)
Additional accident insurance: During employment at Novartis, the employee is insured 24/7 in the event of death or disability resulting from an accident.
Specialist insurance: Group health insurance providing faster access to specialist healthcare services at Triglav Health Insurance Company d.d. for you and your family members.
- Care Connect: A program offering confidential, personalized support for mental health and well-being through therapy, counselling, tools, and more.
- Other benefits in accordance with legislation and collective agreements: Transportation, meal allowance, and other supplements.
Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Skills Desired
Continual Improvement Process, Master Data, Materials Management, Production Planning, Waterfall Model