Expert Engineering (Automation Engineer)/Inženir avtomatizacije

Location: Menges, Slovenia #onsite Klinična proizvodnja | Inženiring in avtomatizacijaSoustvarjajte prihodnost bioloških zdravilV Novartisu soustvarjamo prihodnost zgodnje faze razvoja bioloških zdravil. V okviru te poti se BioCampus Mengeš razvija v najsodobnejši, integriran klinični proizvodni obrat za učinkovino (Drug Substance) in končni izdelek (Drug Product).Za podporo tej rasti iščemo izkušenega inženirja avtomatizacije, ki želi imeti dejanski vpliv v visoko avtomatiziranem, GMP‑reguliranem okolju.Vaša vlogaKot inženir avtomatizacije boste ključni tehnični strokovnjak, odgovoren za avtomatizirane sisteme v proizvodnji in podpornih sistemih. Tesno boste sodelovali z oddelki inženiringa, proizvodnje, zagotavljanja kakovosti (QA), IT/OT ter zunanjimi partnerji, pri čemer boste prispevali tako k tekočemu obratovanju kot tudi k zanimivim novim projektom.To delovno mesto je primerno za posameznika, ki uživa v samostojnosti, tehnični poglobljenosti ter delu na stičišču tehnologije, GMP skladnosti in proizvodne učinkovitosti.Clinical Manufacturing | Engineering & AutomationBe part of building the future of biologicsAt Novartis, we are shaping the future of early‑stage biologics. As part of this journey, BioCampus Mengeš is being developed into a state‑of‑the‑art integrated clinical manufacturing facility for Drug Substance and Drug Product.To support this growth, we are looking for an experienced Automation Engineer (Expert) who wants to make a real impact in a highly automated, GMP‑regulated environment.---Your roleAs an Automation Engineer, you will be a key technical expert responsible for automation systems across manufacturing and supporting utilities. You will work closely with engineering, production, QA, IT/OT and external partners, contributing to both ongoing operations and exciting new projects.This role suits someone who enjoys ownership, technical depth, and working at the interface between technology, GMP compliance and manufacturing performance.

Ključne odgovornostiNačrtovanje, implementacija in vzdrževanje avtomatizacijskih rešitev (PLC, SCADA, DCS, Historian, PIS) v GMP kliničnem proizvodnem okoljuDelovanje kot tehnični lastnik avtomatizacijskih sistemov skozi celoten življenjski cikelSodelovanje pri investicijskih projektih in nadgradnjah: URS, FS/DS, FAT/SAT, IQ/OQ ter predaja sistemov v uporaboZagotavljanje skladnosti z GMP, GxP, načeli integritete podatkov ter internimi standardi NovartisaUpravljanje sprememb na avtomatizacijskih sistemih preko postopkov Change ControlPodpora proizvodnji z odpravljanjem zahtevnih avtomatizacijskih težav in optimizacijo delovanja sistemovSodelovanje z IT/OT oddelkom in dobavitelji za zagotavljanje razpoložljivosti sistemov, kibernetske varnosti in dolgoročne vzdržnostiPodpora pri notranjih in zunanjih revizijah ter inšpekcijahMentorstvo ter tehnična podpora mlajšim inženirjem v ekipiVaš profilUniverzitetna izobrazba s področja avtomatizacije, elektrotehnike, mehatronike, računalništva ali sorodnih smeriVsaj 5 let ustreznih delovnih izkušenj, od tega najmanj 2 leti v GMP‑reguliranem okolju (farmacija, biotehnologija ali kemijska industrija)Močne praktične izkušnje s sistemi PLC / SCADA / DCS ter industrijskimi omrežjiIzkušnje z validacijo računalniških sistemov (CSV) in regulirano dokumentacijoSposobnost samostojnega dela, sprejemanja utemeljenih tehničnih odločitev ter jasnega komuniciranja z različnimi deležnikiRole: Expert Engineering (Automation Engineer)Location: Mengeš, Slovenia | BioCampus – Novartis🧬 Clinical Manufacturing | Engineering & AutomationBe part of building the future of biologicsAt Novartis, we are shaping the future of early‑stage biologics. As part of this journey, BioCampus Mengeš is being developed into a state‑of‑the‑art integrated clinical manufacturing facility for Drug Substance and Drug Product.To support this growth, we are looking for an experienced Automation Engineer (Expert) who wants to make a real impact in a highly automated, GMP‑regulated environment.---Your roleAs an Automation Engineer, you will be a key technical expert responsible for automation systems across manufacturing and supporting utilities. You will work closely with engineering, production, QA, IT/OT and external partners, contributing to both ongoing operations and exciting new projects.This role suits someone who enjoys ownership, technical depth, and working at the interface between technology, GMP compliance and manufacturing performance.---Key responsibilitiesDesign, implement and maintain automation solutions (PLC, SCADA, DCS, Historian, PIS) in a GMP clinical manufacturing environmentAct as technical owner of automation systems across their full lifecycleParticipate in capital projects and upgrades: URS, FS/DS, FAT/SAT, IQ/OQ and system handoverEnsure compliance with GMP, GxP, Data Integrity and Novartis internal standardsManage automation‑related changes through Change Control processesSupport production by troubleshooting complex automation issues and optimising system performanceCollaborate with IT/OT and vendors to ensure system availability, cybersecurity and long‑term sustainabilitySupport internal and external audits and inspectionsCoach and technically support junior engineers within the team---What you bringUniversity degree in Automation, Electrical Engineering, Mechatronics, Computer Science or similar5+ years of relevant experience, with at least 2 years in a GMP‑regulated (pharma, biotech or chemical) environmentStrong hands‑on experience with PLC / SCADA / DCS systems and industrial networksExperience with computer system validation (CSV) and regulated documentationAbility to work independently, make sound technical decisions and communicate clearly with multiple stakeholders