Job Description

Location: Menges, Slovenia #onsite

Klinična proizvodnja | Inženiring in avtomatizacija
Soustvarjajte prihodnost bioloških zdravil
V 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 vloga
Kot 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 & Automation
Be part of building the future of biologics
At 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.
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Your role
As 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 odgovornosti

• Načrtovanje, implementacija in vzdrževanje avtomatizacijskih rešitev (PLC, SCADA, DCS, Historian, PIS) v GMP kliničnem proizvodnem okolju
• Delovanje kot tehnični lastnik avtomatizacijskih sistemov skozi celoten življenjski cikel
• Sodelovanje pri investicijskih projektih in nadgradnjah: URS, FS/DS, FAT/SAT, IQ/OQ ter predaja sistemov v uporabo
• Zagotavljanje skladnosti z GMP, GxP, načeli integritete podatkov ter internimi standardi Novartisa
• Upravljanje sprememb na avtomatizacijskih sistemih preko postopkov Change Control
• Podpora proizvodnji z odpravljanjem zahtevnih avtomatizacijskih težav in optimizacijo delovanja sistemov
• Sodelovanje z IT/OT oddelkom in dobavitelji za zagotavljanje razpoložljivosti sistemov, kibernetske varnosti in dolgoročne vzdržnosti
• Podpora pri notranjih in zunanjih revizijah ter inšpekcijah
• Mentorstvo ter tehnična podpora mlajšim inženirjem v ekipi

Vaš profil

• Univerzitetna izobrazba s področja avtomatizacije, elektrotehnike, mehatronike, računalništva ali sorodnih smeri
• Vsaj 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 omrežji
• Izkušnje z validacijo računalniških sistemov (CSV) in regulirano dokumentacijo
• Sposobnost samostojnega dela, sprejemanja utemeljenih tehničnih odločitev ter jasnega komuniciranja z različnimi deležniki

Role: Expert Engineering (Automation Engineer)
Location: Mengeš, Slovenia | BioCampus – Novartis
🧬 Clinical Manufacturing | Engineering & Automation

Be part of building the future of biologics
At 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 role
As 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
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Key responsibilities

• Design, implement and maintain automation solutions (PLC, SCADA, DCS, Historian, PIS) in a GMP clinical manufacturing environment
• Act as technical owner of automation systems across their full lifecycle
• Participate in capital projects and upgrades: URS, FS/DS, FAT/SAT, IQ/OQ and system handover
• Ensure compliance with GMP, GxP, Data Integrity and Novartis internal standards
• Manage automation‑related changes through Change Control processes
• Support production by troubleshooting complex automation issues and optimising system performance
• Collaborate with IT/OT and vendors to ensure system availability, cybersecurity and long‑term sustainability
• Support internal and external audits and inspections
• Coach and technically support junior engineers within the team

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What you bring

• University degree in Automation, Electrical Engineering, Mechatronics, Computer Science or similar
• 5+ years of relevant experience, with at least 2 years in a GMP‑regulated (pharma, biotech or chemical) environment
• Strong hands‑on experience with PLC / SCADA / DCS systems and industrial networks
• Experience with computer system validation (CSV) and regulated documentation
• Ability to work independently, make sound technical decisions and communicate clearly with multiple stakeholders

Skills Desired