AS&T specialist II – Microbiology

Postani del izjemne zgodbe na Brniku
Vzpostavljamo najsodobnejši center za proizvodnjo sterilnih podobnih bioloških zdravil, ki bo s pomočjo najnovejše tehnologije omogočil dostop do kakovostnih in cenovno dostopnih podobnih bioloških zdravil po vsem svetu. Pridruži se ekipi, ki ustvarja prihodnost farmacije – danes.

Kot 
AS&T (Analitske znanosti in tehnologije) Specialist II
 
(d/ž/m)
boste član ekipe, ki je odgovorna za načrtovanje, upeljevanje in zagon novega najsodobnejšega mikrobiološkega laboratorija. Med vaše naloge bo sodila izbira ustrezne opreme, kvalifikacija opreme, validacija procesov, izvajanje mikrobioloških študij, verifikacij in eksperimentov. Odgovorni boste za interpretacijo in poročanje rezultatov z namenom zagotavljanja pravočasne in kakovostne podpore projektom oziroma procesom. Prispevali boste tudi k nadgradnji in prenosu strokovnega znanja ter izvajali aktivnosti, povezane s tehnološkimi izboljšavami. Poleg tega boste prevzeli odgovornost za vso analitsko dokumentacijo. Aktivno boste prispevali k tehnološkim izboljšavam in optimizaciji procesov, pri tem pa zagotavljali skladnost z veljavno zakonodajo, internimi postopki, dobrimi praksami in poslovnimi cilji.

Vaše ključne odgovornosti:

• Vodenje razvoja metod, validacij, primerjav in prenosov, vključno s pripravo obsežnih poročil.
• Uvajanje novih tehnik in tehnologij ter optimizacija obstoječih metod za izboljšanje učinkovitosti.
• Odgovornost za kvalifikacijo opreme, kalibracijo, vzdrževanje ter obravnavo izzivov v skladu z GxP zahtevami.
• Aktivna podpora projektom, povezanih s proizvodnjo, vključno z validacijami izdelkov, procesov in kvalifikacij.
• Strokovna podpora pri reševanju kompleksnih težav, odstopov in sprememb ter pripravi ocene tveganja.
• Delovanje v skladu s slovensko in evropsko zakonodajo, smernicami FDA, mednarodnimi standardi in načeli integritete podatkov.
• Prispevanje k razvoju in nadzoru sistema kakovosti ter aktivno sodelovanje pri notranjih in zunanjih presojah.
• Udeležba na obveznih usposabljanjih, deljenje znanja ter prevzemanje odgovornosti za osebni in strokovni razvoj.

Vaš doprinos k delovnem mestu:

• Visokošolska stopnja izobrazbe mikrobiološke, biotehnološke, biološke, biokemijske ali druge naravoslovne smeri.
• Zaželene delovne izkušnje iz mikrobiološkega laboratorija, kliničnega laboratorija, mikrobiološkega inštituta, raziskovalnega mikrobiološkega laboratorija, farmacevtske proizvodnje ali drugega ustreznega področja.
• Aktivno znanje angleškega jezika.
• Poznavanje orodja Microsoft Office.

Kaj nudimo:

Zaposlitev pri najuglednejšem delodajalcu v Sloveniji vam prinaša 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.

Možne lokacije dela: 
Slovenija
(Ljubljana, Brnik)

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

• Prijave z življenjepisom v angleškem in slovenskem jeziku lahko oddate najkasneje do 
  
  preko spletne povezave.

With its strategic investments in Slovenia, Sandoz is not just building factories – we are building the future: for science, for people, and for global healthcare. To bring this vision to life, we are looking for dedicated, motivated, and passionate professionals who will contribute their knowledge and commitment to co-create a story of success.

As an 
AS&T (Analytical Science and Technology) Specialist II (d/f/m)
, you will be a member of a team that is responsible for planning, initiating and launching a new state of the art microbiological laboratory. The activities in your responsibility will be selection of relevant equipment, equipment qualification, validation of selected processes, conducting microbiological studies, verifications, and experiments. You will be accountable for interpreting and reporting results to ensure timely and high-quality support for projects or processes. You will also contribute to the enhancement and transfer of expert knowledge and carry out activities related to technological improvements. Furthermore, you will take responsibility for all analytical documentation. You will actively contribute to technological improvements and process optimization, while ensuring compliance with applicable legislation, internal procedures, good practices, and business objectives.

Your key responsibilities:

Your responsibilities include, but not limited to:

• Leading method development, validation, comparisons, and transfers, including preparation of comprehensive reports.
• Introducing new techniques and technologies and optimizing existing methods to enhance efficiency and performance.
• Responsibility for equipment qualification, calibration, maintenance, and handling malfunctions in compliance with GxP requirements.
• Providing active support for production-related projects, including product, process, and qualification validations.
• Providing expert support in resolving complex issues, managing exceptions and changes, and preparing risk assessments.
• Operating in accordance with Slovenian and European legislation, FDA guidelines, international standards, and data integrity principles.
• Contributing to the development and oversight of the quality system, and actively participating in internal and external audits.
• Attending mandatory trainings, sharing knowledge, and taking responsibility for personal and professional growth.

What you will bring to the role:

• University-level education in microbiology, biotechnology, biology, biochemistry or another natural science discipline.
• Preferred work experience in microbiological laboratory like clinical, research and development, environmental, or another relevant field.
• Active proficiency in English.
• Familiarity with Microsoft Office tools.

You'll receive:

Employment at the most reputable employer in Slovenia offers 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.

Possible job locations: 
Slovenia
(Ljubljana, Brnik)

We offer 
permanent contract with 6-month of probation period
.

You are kindly invited to submit your application in English language, including CV, by