Resumen
About the Role
Key Responsibilities:
- System Installation and Configuration: Perform the installation and configuration of the MES software, working closely with the vendor and IT teams. Ensure proper integration with existing systems and data sources and troubleshoot any technical issues that may arise during the installation process.
- Validation: Develop and execute validation protocols (e.g. Installation Qualification, Operational and Performance Qualification) to verify the functionality and compliance of our MES with regulatory standards. Your meticulous approach will ensure that our system meets all necessary requirements. In collaboration with business stakeholders, you will ensure that overall validation lifecycle is in place and maintained.
- Vendor Collaboration: Collaborate with our trusted vendor to gather user requirements and ensure the system's capabilities align with the organization's manufacturing processes. Provide input on system design, assess technical feasibility, and manage the procurement process in coordination with the vendor.
- Integration and Digitalization: Integrate our solutions into Novartis ecosystem. You will be responsible for end-to-end integration between the system ensuring that relevant data is exchanged and available per business requirements. MES plays an important role on our digital journey hence you will have a chance to impact how we transform our ways of working.
- Continuous Improvement: Continuously monitor and evaluate the performance of our MES to identify areas for optimization. Work closely with business stakeholders on translation of business requirements into a technical solution. You will be part of the business community where you will have a chance to work with different sites worldwide.
- Successful Implementation: Ensure the successful implementation of the Manufacturing Execution System within project timelines, budget, and quality standards. This includes completing all necessary tasks, such as requirements gathering, server provisioning, installation, and configuration, while adhering to project goals and delivering the system on time and within budget.
- Compliance with Validation Protocols and Regulatory Requirements: Validate the functionality and compliance of the MES system by executing validation protocols and ensuring adherence to regulatory standards. The absence of critical or major observations during internal and external inspections indicates a successful compliance record.
- Stable Operations and System Uptime: Maintain stable operations of the MES system with minimal downtime and interruptions. Measure and track system uptime to ensure optimal availability and performance, meeting the defined Key Performance Indicators (KPIs) as per the Service Level Agreement.
- User Satisfaction: Gather feedback from end-users to evaluate their satisfaction with the MES system. Conduct regular surveys or interviews to assess the usability, effectiveness, and user experience of the system. A high level of user satisfaction indicates a successful implementation that meets the needs and expectations of the users.
Requirements:
- Bachelor's degree in a computer science, engineering or information technology discipline. An advanced degree and related accreditations a plus.
- Experience in GxP environment and understanding of pharmaceutical manufacturing processes and technologies are an advantage but not essential.
- Fluent English (written and verbal)
- Experience in MES systems.
- Digital and Tech savvy
You are kindly invited to submit your application in English language, including CV.
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive:
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.
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.
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
For Slovenia:
NAZIV DELOVNEGA MESTA: Strokovnjak za izvedbo proizvodnega sistema (m/ž/d)
OPIS DEL IN NALOG
Lokacija:
Iščete vznemirljivo priložnost za delo z najnovejšimi tehnologijami, sodelovanje s super ekipo in delo v okolju visoko usposobljenih strokovnjakov? Iščemo talentiranega in motiviranega sodelavca, ki se bo pridružil naši ekipi za proizvodni IT v podjetju Novartis.
Ste strastni pri uresničevanju in vzdrževanju sistemov za izvajanje proizvodnje, s katerimi optimizirate proizvodne procese? Pridružite se naši ekipi kot <b> strokovnjak za izvedbo proizvodnega sistema (m/ž/d) </b in igrajte ključno vlogo pri uspehu naše organizacije.
<b>Vaše ključne odgovornosti:</b>
- Namestitev in konfiguracija sistema: Izvedajanje namestitev in konfiguracije programske opreme za izvedbo proizvodnega sistema (MES), tesno boste sodelovali z dobavitelji in IT-ekipo. Zagotavljali boste pravilno integracijo z obstoječimi sistemi in viri podatkov ter odpravljali morebitne tehnične težave, ki se lahko pojavijo med namestitvenim postopkom.
- Validacija: Razvijanje in izvedba protokolne validacije (npr. preverjanje ustreznosti namestitve, operativna in uspešnostna preverjanja), preverjanje funkcionalnosti in skladnosti našega MES z zakonodajnimi standardi. Vaš natančen pristop bo zagotovil, da bo naš sistem izpolnjeval vse potrebne zahteve. V sodelovanju z zainteresiranimi deležniki boste poskrbeli, da bo celoten življenjski cikel validacije vzpostavljen in vzdrževan.
- Sodelovanje z dobavitelji: Sodelovali boste z zaupanja vrednim dobaviteljem, da pridobite uporabniške zahteve in zagotovite, da se funkcionalnosti sistema ujemajo s proizvodnimi procesi organizacije. Sodelovali boste pri načrtovanju sistema, ocenili tehnično izvedljivost in upravljali proces nabave v sodelovanju z dobaviteljem.
- Integracija in digitalizacija: Vključite naše rešitve v Novartisov ekosistem. Odgovorni boste za celovito integracijo med sistemom, da se zagotovi izmenjava ustreznih podatkov v skladu z zahtevami poslovanja. MES ima pomembno vlogo v našem digitalnem potovanju, zato boste imeli priložnost vplivati na način, kako preoblikujemo naše načine dela.
- Neprekinjeno izboljševanje: Vaša naloga bo tudi neprestano spremljanje in ocenjevanje delovanje našega MES sistema, da boste identificirali področja za optimizacijo. Tesno boste sodelovali z zainteresiranimi deležniki pri prevajanju poslovnih zahtev v tehnične rešitve. Boste del poslovne skupnosti, kjer boste imeli priložnost sodelovati z različnimi lokacijami po vsem svetu.
- Uspešna implementacija: Skrbrli boste za uspešno implementacijo sistema za izvajanje proizvodnje v okviru časovnega načrta, proračuna in standardov kakovosti projekta. To vključuje izpolnjevanje vseh potrebnih nalog, kot so zbiranje zahtev, zagotavljanje strežnika, namestitev in konfiguracija, ob upoštevanju ciljev projekta ter pravočasno in v okviru proračuna dostavo sistema.
- Skladnost s protokoli validacije in zakonodajnimi zahtevami: Preverjali boste funkcionalnost in skladnost sistema MES z izvajanjem validacijskih protokolov in zagotovitev spoštovanja zakonodajnih standardov.
- Stabilno delovanje sistema in dosegljivost: Vaša naloga bo ohranjanje stabilnega delovanja sistema za izvajanje proizvodnje z minimalnim časom nedelovanja in prekinitvami, meritve in sledenje dosegljivosti sistema za zagotavljanje optimalne razpoložljivosti in uspešnosti, tako da izpolnjujejo določene kazalnike ključne uspešnosti (KPI) v skladu s sporazumom o ravni storitve.
- Zadovoljstvo uporabnikov: Vaša naloga bo tudi zbiranje povratnih informacij uporabnikov, da ocenite njihovo zadovoljstvo z sistemom MES. Redno bo potrebno izvajanje anket ali intervjujev, za oceno uporabnosti, učinkovitosti in uporabniško izkušnjo sistema.
Video link: [#video#https://www.youtube.com/watch?v=ggbnzRY9z8w&feature=emb_title{#400,300#}#/video#]
Minimalne zahteve
<b>Vaš doprinos k delovnem mestu:</b>
- Visokošolska stopnja izobrazbe računalniške strojne ali druge ustrezne smeri.
- Aktivno znanje angleškega jezika.
- Delo v multifunkcionalnem timu.
- Sposobnost obvladovanja izzivov in proaktivno razmišljanje.
- Dobre komunikacijske veščine in pripravljenost za učenje novih tehnologij.
- Zaželjene so delovne izkušnje v GxP okolju in poznavanje farmacevtskih proizvodnih procesov.
- Zaželjeno poznavanje tehnologij (npr. Oracle, Kafka...)
<b>Zakaj Novartis? </b>
Naš namen je soustvarjati medicino za izboljšanje in podaljševanje življenja ljudi, naša vizija pa je postati najbolj cenjeno in zaupanja vredno farmacevtsko podjetje na svetu. Kako lahko to dosežemo? S pomočjo naših ljudi. Prav naši sodelavci nas vsak dan spodbujajo, da dosežemo svoje ambicije. Postanite del te misije in se nam pridružite! Več na spodnji povezavi: https://www.novartis.com/about/strategy/people-and-culture
<b>Kaj nudimo: </b>
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.
<b>Predani smo raznolikosti in vključenosti</b>
Novartis si prizadeva ustvariti izjemno, vključujoče delovno okolje in oblikovanje raznolikih timov, saj ti predstavljajo naše bolnike in skupnosti, ki jih oskrbujemo.
<b>Pridružite se naši mreži Novartis:</b> V kolikor se ne prepoznate v zgornjem opisu delovnega mesta, vas vabimo, da se vpišete na spodnji povezavi v Novartisovo bazo talentov saj lahko tako vašo vlogo upoštevamo za podobne pozicije v prihodnosti: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
![A female Novartis scientist wearing a white lab coat and glasses, smiles in front of laboratory equipment. A female Novartis scientist wearing a white lab coat and glasses, smiles in front of laboratory equipment.](/themes/custom/polaris/patterns/images/careers-default-image.webp)