Novartis
Tehnolog proizvodnih procesov (m/ž/d) / Process Expert (m/f/d)
🇸🇮Mengeš, Mengeš, Slovenia17 days ago
SeniorFull TimeEurope
Job Description Summary
#LI-Hybrid
Job Description
Vaše ključne odgovornosti:
Vzpostavitev in optimizacija polnilne izolatorske linije za zagotovitev učinkovitega in kakovostnega polnjenja končnih izdelkov.
Izvajanje spremljanja pogojev okolja, tako živih kot neživih delcev, da se ohrani in zagotovi ustrezno proizvodno okolje.
Obvladovanje validacije aseptičnega polnjenja za zagotovitev sterilnosti procesa polnjenja končnih izdelkov.
Izvajanje testiranja integritete primarne ovojnine (CCIT), da se zagotovi celovitost in varnost izdelka.
Obvladovanje vizualne kontrole končnih izdelkov: Imeli boste ključno vlogo pri zagotavljanju najvišjih standardov kakovosti s strokovnim upravljanjem inherentnih, intrinzičnih in ekstrinzičnih delcev v proizvodnji končnih izdelkov.
Strokovno znanje o primarni ovojnini (viale): Vaše znanje in izkušnje s primarno ovojnino bodo ključnega pomena pri zagotavljanju varnosti naših zdravil.
Sekundarna ovojnina: Kot strokovnjak za sekundarno ovojnino boste prispevali k učinkovitemu in natančnemu pakiranju naših zdravil, ki rešujejo življenja.
Vaš doprinos k delovnem mestu:
Diploma iz biotehnologije, kemije, farmacije ali druge naravoslovno znanstvene smeri. Zaželen tudi magisterij ali enakovredne izkušnje.
Minimalno 3 leta izkušenj na področju podpornih procesov v proizvodnem obratu v skladu z GMP in/ali zagotavljanja kakovosti (QA)/kontrole kakovosti (QC).
Dokazano razumevanje procesov (farmacevtska praksa, dobra proizvodna praksa, regulativni vidiki).
Zaželeno poznavanje aseptične proizvodnje, aseptičnih tehnik.
Tekoče znanje angleščine in slovenščine.
Poznavanje orodij Microsoft Office.
Z izbranim kandidatom bomo sklenili delovno razmerje za določen čas 1 leta s poskusno dobo 6 mesecev in z možnostjo podaljšanja.
Ugodnosti in nagrajevanje:
Konkurenčen plačni paket, letni bonus, fleksibilen način dela z možnostjo prilagajanja urnika in delom od doma, pokojninska shema, shema nagrajevanja in priznanja dosežkov, razširjeni program promocije zdravja na področju telesnega, duševnega in fizičnega počutja (iniciativa Polni življenja), številne priložnosti za učenje in razvoj.
Preberite naš priročnik, da spoznate načine, s katerimi bomo spodbujali vaš osebni in profesionalni razvoj: https://www.novartis.com/careers/benefits-rewards
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 Novartisu: Ni pravo delovno mesto za vas? Prijavite se v našo bazo talentov, da ostanete v kontaktu z nami in se seznanite z ustreznimi kariernimi priložnostmi takoj, ko se pojavijo: https://talentnetwork.novartis.com/network
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English version:
Key Responsibilities:
Setting up and optimizing the isolator filling line to ensure efficient and high-quality production.
Conducting comprehensive environmental monitoring, both for viable and non-viable particles, to maintain a pristine manufacturing environment.
Managing media fill activities to validate and ensure the sterility of our filling processes.
Implementing Container Closure Integrity Testing (CCIT) procedures to guarantee product integrity and safety.
Management of visual control for DP: You will play a crucial role in ensuring the highest standards of quality by expertly managing inherent, intrinsic, and extrinsic particles in drug product manufacturing.
Expertise in primary packaging (vials): Your knowledge and experience in primary packaging will be instrumental in guaranteeing the integrity and safety of our drug products.
Secondary packaging: As an expert in secondary packaging, you will contribute to the efficient and accurate packaging of our life-saving medications.
What you will bring to the role:
BSc. in biotechnology, chemistry, pharmacy, or another natural science discipline. A Master’s degree or equivalent experience is preferred.
Minimum 3 years of experience in process support role on the shop floor of GMP manufacturing and/or QA/QC.
Proven process understanding (Pharma, GMP, Regulatory aspects).
Knowledge of aseptic manufacturing and aseptic techniques is an advantage.
Fluent in English and Slovenian.
Proficiency in Microsoft Office tools.
We offer temporary employment for 1 year with 6 months of probation period and the possibility of extension.
Benefits and Rewards:
Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, possibility of joining collective health insurance scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical and mental well-being and managing workload (Well-being), 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
Skills Desired
Change Control, Chemical Engineering, Continual Improvement Process, Efficiency, Flexibility (Inactive), General Hse Knowledge, Good Documentation Practice, Knowledge Of Capa, Knowledge Of Gmp, Manufacturing Process, Manufacturing Production, Process Control, Productivity, Risk Management, Root Cause Analysis (RCA), Scheduler, Technology Transfer
