Ekspert tehnologije izdelkov (m/ž/d) / Product Steward (m/f/d)

Salary Range: 32.060,00 € - 59.540,00 € Band Level 4 Job Description Summary #LI-Hybrid Lokacija/Location: Mengeš, Slovenija Interni naziv: Ekspert tehnologije izdelkov I (m/ž/d) / Product Steward I (m/f/d) Relocation Support: This role is based in Mengeš, Slovenia. Novartis is unable to offer relocation support: please only apply if accessible. Vas navdušuje biotehnologija, uživate v reševanju kompleksnih tehničnih izzivov in se dobro znajdete v sodelovalnem ter dinamičnem okolju? Pridružite se naši ekipi MS&T DS Bioproduction v Mengšu in soustvarjajte prihodnost proizvodnje bioloških učinkovin. V Novartisu združujemo znanstveno odličnost, napredne proizvodne tehnologije in kulturo nenehnih izboljšav, da bolnikom po vsem svetu zagotavljamo visokokakovostna zdravila. V vlogi Ekspert tehnologije izdelkov boste strokovnjak za izdelek in proces skozi celoten komercialni življenjski cikel bioloških učinkovin. Skrbeli boste za poglobljeno razumevanje procesov, podpirali odločanje na podlagi podatkov, sodelovali pri aktivnostih upravljanja življenjskega cikla izdelka ter tesno sodelovali z medfunkcijskimi ekipami za zagotavljanje robustnih proizvodnih procesov, regulatorne skladnosti in zanesljive oskrbe z zdravili. ___________ Ready to make a meaningful impact on the medicines patients rely on every day? Join our MS&T DS Bioproduction team in Mengeš and help shape the future of biologics manufacturing. At Novartis, we combine scientific excellence, advanced manufacturing technologies, and a culture of continuous improvement to deliver high-quality medicines to patients worldwide. As a Product Steward I, you will be the product and process expert throughout the commercial lifecycle of biologic drug substances. You will own process knowledge, drive data-based decision-making, support lifecycle management activities, and work closely with cross-functional teams to ensure robust manufacturing processes, regulatory compliance, and reliable product supply. Job Description Vaše ključne odgovornosti: Skrb za strokovno znanje o izdelku in procesu skozi celoten življenjski cikel komercialnega biološkega zdravila. Spremljanje učinkovitosti procesov z analizo trendov podatkov in statističnimi analizami ter prepoznavanje priložnosti za nenehne izboljšave. Zagotavljanje strokovne podpore in nadzora nad procesi proizvodnje bioloških učinkovin. Priprava, pregledovanje in vzdrževanje tehnične, validacijske ter dokumentacije za upravljanje življenjskega cikla izdelka. Vodenje in podpiranje preiskav odstopanj, analiz temeljnih vzrokov ter izvajanja korektivnih in preventivnih ukrepov (CAPA). Ocenjevanje tehničnih sprememb ter njihovega vpliva na kakovost izdelka, učinkovitost procesov in skladnost z zahtevami. Sodelovanje z medfunkcijskimi ekipami pri upravljanju življenjskega cikla izdelkov, regulatornih aktivnostih in zagotavljanju pripravljenosti na inšpekcijske preglede. Podpora pri uvajanju novih izdelkov, procesov in tehnologij v proizvodno okolje. Prispevanje k pripravi regulatorne dokumentacije ter zagotavljanju skladnosti z internimi in zunanjimi zahtevami. Aktivno sodelovanje pri pobudah za operativno odličnost, optimizacijo procesov ter izmenjavo strokovnega znanja. Vaš doprinos k delovnem mestu: Univerzitetna izobrazba s področja biotehnologije, farmacije, kemije, kemijskega inženirstva, farmacevtske tehnologije ali druge ustrezne naravoslovne smeri. Najmanj pet let izkušenj v proizvodnji bioloških učinkovin ali v farmacevtski proizvodnji. Dobro poznavanje biofarmacevtskih proizvodnih procesov, vključno z upstream in downstream procesnimi tehnologijami. Izkušnje s tehnično dokumentacijo, validacijskimi aktivnostmi in upravljanjem življenjskega cikla izdelkov. Poznavanje zahtev dobre proizvodne prakse, sistemov kakovosti in regulatornih smernic. Razvite komunikacijske sposobnosti, sposobnost upravljanja deležnikov ter učinkovitega sodelovanja v medfunkcijskih ekipah v globalnem okolju. Zaželene izkušnje : Izkušnje z vodenjem projektov v medfunkcijskem okolju. Izkušnje z uporabo statističnih orodij in analizo podatkov. Z izbranim kandidatom bomo sklenili delovno razmerje za nedoločen čas s poskusno dobo 6 mesecev . Prijavo oddajte z življenjepisom v slovenskem in angleškem jeziku. 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: 32.060 – 59.540 € 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 3.054,65 €). Zavarovanje: 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: 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. _____________________________________________ Key responsibilities: Own product and process knowledge throughout the commercial biologics product lifecycle. Monitor process performance through data trending and statistical analysis to drive continuous improvement. Maintain oversight of drug substance manufacturing processes and provide expert process support. Create, review, and maintain technical, validation, and lifecycle management documentation. Lead and support investigations, root-cause analyses, and implementation of corrective and preventive actions. Assess technical changes and evaluate impacts on product quality, process performance, and compliance. Collaborate across functions to support lifecycle management, regulatory activities, and inspection readiness. Support the introduction of new products, processes, and technologies into the manufacturing environment. Contribute to the preparation of regulatory documentation and ensure compliance with internal and external requirements. Actively participate in operational excellence initiatives, process optimization efforts, and knowledge-sharing activities. Essential Requirements University degree in Biotechnology, Pharmacy, Chemistry, Chemical Engineering, Pharmaceutical Technology, or another relevant scientific field. Minimum five years of experience in biologics manufacturing, or pharmaceutical manufacturing. Strong understanding of biopharmaceutical manufacturing processes, including upstream and downstream processing technologies. Experience with technical documentation, validation activities, and product lifecycle management. Knowledge of Good Manufacturing Practice requirements, quality systems, and regulatory guidelines. Strong communication, stakeholder management, and cross-functional collaboration skills in a global environment. Desirable Requirements Experience leading projects in a cross-functional environment. Experience using statistical tools and performing data analysis. We offer permanent employment with 6 months of probation period. Submit your application with the CV in Slovenian and English language. 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: €32.060 – 59.540 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 €3,054.65). Insurance: 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: 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 Applied Statistics, Manufacturing Production, Manufacturing Technologies, Operational Excellence, Process Control, Quality Compliance, Regulatory Compliance, Technical Leadership, Technology Transfer