382933BR
Jul 03, 2024
Slovenia

Summary

Kot Tehnolog proizvodnih procesov specialist (ž/m/d) v Bioprodukciji Mengeš boste zagotavljali kompleksno strokovno podporo za vsa vprašanja, povezana s procesi v proizvodnji, v enem ali več proizvodnih korakih, da bi zagotovili pravočasno izvedbo kompleksnih procesov, nenehno izboljševanje kakovosti in produktivnosti, ki se izvajajo v skladu s cGMP, SOP ter veljavnimi smernicami in funkcionalnimi standardi (npr. ZVO ...). As Senior Process Expert (m/f/d) in Bioproduction Mengeš you will provide front line complex expert support for all process-specific issues to production within one or more complex production steps, to ensure execution of complex processes on-time, continuously improving in quality and productivity, performed in compliance to cGMPs, SOPs and applicable guidelines and functional standards (e.g. HSE...).

About the Role

Ključne odgovornosti:

- Upravljanje kompleksnih proizvodnih procesov in procesnih tehnologij.

- Upravljanje metod za odpravljanje težav v rRCI.

- Zagotavljanje pravočasne obravnave odstopanj, pritožb, eskalacij, OOE, OOS in izvajanje učinkovitih CAPA v dogovorjenih rokih.

- Optimizacija proizvodnih procesov in procesnih tehnologij.

- Upravljanje sprememb, povezanih s proizvodi in zagotavljanje strokovne učinkovitosti.

- Načrtovanje in zagotavljanje skladnosti tehnoloških postopkov (validacija, čiščenje, sterilizacija) ter izdelava tehnološke dokumentacije.

- Odgovornost za nadgradnjo in prenos strokovnega znanja ter izvajanje novih tehnologij.

- Delovanje kot kontaktna oseba za platformo, podpora globalnim pobudam, zastopanje lokacije na globalni ravni.

Vaš doprinos k delovnem mestu:

- Diploma iz farmacevtske tehnologije, kemije, farmacije ali enakovredne znanstvene izobrazbe. Zaželen magisterij znanosti ali enakovredne izkušnje.

- Zaželene so izkušenje v podpornem procesu v proizvodni hali in/ali kakovosti.

- Razumevanje procesov (farmacija, GMP, regulativni vidiki).

- Tekoče znanje angleščine in slovenščine.

- Obvladanje orodij Microsoft Office.

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

Zakaj Novartis?
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

Kaj nudimo:
Konkurenčen plačni paket, letni bonus, fleksibilen način dela, z možnostjo prilagajanja urnika in delom od doma, zaposlitev v podjetju s certifikatom TOP Employer, 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.

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.

Pridružite se naši mreži Novartis: 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

English version:

Key Responsibilities:


• Management of complex manufacturing processes and process technologies.
• Management of methods for trouble shooting in rRCI.
• Ensure timely treatment of deviations, complaints, escalations, OOE, OOS, and the implementation of effective CAPAs within agreed timelines.
• Optimization of manufacturing processes and process technology.
• Management of product-related changes, and assurance of professional efficiency.
• Planning and assurance of conformity of technological processes (validation, cleaning, sterilization) and generation of technological documentation.
• Responsibility for upgrading and transfer of expertise, and implementation of new technologies.
• Act as point of contact for platform, support global initiatives as assigned, represent site at global level.

What you'll bring to the role:

• BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy
or equivalent scientific degree. Desirable MSc. or equivalent experience.
• Desired experience in process support role on the shop floor of
manufacturing and/or quality.
• Process understanding (Pharma, GMP, Regulatory aspects).
• Fluent in English and proficient in Slovene language.
• Knowledge of Microsoft Office.

We offer permanent employment with 6 months of probation period.


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 morehere: 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

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

Operations
Innovative Medicines
Slovenia
Mengeš
Technical Operations
Full time
Regular
No

Accessibility and accommodation

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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382933BR

Tehnolog proizvodnih procesov specialist (ž/m/d)/Senior Process Expert (f/m/d)

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