Alvotech hf
Alvotech er fjölþjóðlegt hátæknifyrirtæki í fremstu röð, þar sem yfir 1000 starfsmenn af um 64 þjóðernum vinna að því að móta framtíðina á sviði líftæknilyfja og auka aðgengi sjúklinga um allan heim að hágæða lyfjum. Margir af færustu vísindamönnum landsins starfa hjá fyrirtækinu.
Við leyfum fjölbreytileika, forvitni og frumkvæði starfsfólks að njóta sín. Við bjóðum aðlaðandi starfsumhverfi í stöðugri mótun og ögrandi verkefni. Alvotech tryggir að jafnrétti kynjanna til launa og frama nái til allra starfsmanna, hérlendis jafnt sem erlendis. Við viljum laða að okkur færasta fólkið á hverju sviði, án tillits til uppruna eða kyns. Með þessum hætti getum við best þjónað hagsmunum sjúklinga og samstarfsaðilum okkar.
Vertu með okkur í að bæta lífsgæði fólks og auka aðgengi að hagkvæmum líftæknilyfjum.
Technical Process Engineer F&F MSAT
Technical expert in one or more control systems like RABS, Isolator technology, Combi line (PFS & Vial), SFM HMI, Filter integrity tester, parts washer, and steam sterilizer platforms used in DP Manufacturing. Lead or support all Commissioning & Qualification (C&Q) activities within the DPM area. Responsible for recipe creation/modification for process equipment in the DPM area.
Helstu verkefni og ábyrgð
- Lead or support all Commissioning & Qualification (C&Q) activities within the DPM area.
- Responsible for recipe creation/modification for process equipment in the DPM area.
- The holder of this position will be a technical expert in one or more control systems like Isolator technology, Combi line (PFS & Vial), SFM HMI, Filter integrity tester, parts washer, and steam sterilizer platforms used at the Reykjavik site.
- Coordinate with the qualification team for ordering the consumables and manufacturing components required for new process qualification activities.
- Be an SME author/reviewer and/or approver for written procedures, SOPs, protocols, comparability protocols sample plans and reports, etc.
- Be an author/reviewer/SME for deviations, CAPAs, and Change controls relating to DPM equipment and process and responsible for OOS/OOT/OOR Phase II investigation.
- Be an SME author for performing risk assessments relating to DPM processes.
- Basic Automation and Instrumentation Knowledge.
- Ability to write protocols and report technical information in written and verbal format.
- Detailed knowledge of Drug Product manufacturing and handling of instruments.
Menntunar- og hæfniskröfur
- Education: A minimum of BSc or MSc in a technical discipline (e.g., pharmacy, biotechnology, biochemistry, engineering, or a related field) preferred.
- Experience: Minimum 5-10 years relevant experience working with industrial control systems.
- Minimum 5-10 years of relevant experience working with industrial control systems.
- Significant technical experience working with and supporting one or more of the control system platforms used at the Reykjavik sites (Delta V, Siemens PLC/SCADA).
- Skills: A team player with strong leadership and organizational skills. Excellent written and verbal communication skills. Proficient in using a PC and common Microsoft packages such as Word, Visio, and Excel.
Fríðindi í starfi
- An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
- The chance to be a part of a global and fast-growing company.
- An international work culture that encourages diversity, collaboration and inclusion.
- Positive, flexible, and innovative work environment.
- Support for personal growth and internal career development.
- Company social events and milestone celebrations.
- Excellent in-house canteen and coffee house.
- Exercise and wellbeing support for full-time employees.
- On-site shower facility.
- Transportation grant towards eco-friendly modes of travel for full-time employees.
- Internet at home for full-time employees.
Auglýsing birt30. október 2024
Umsóknarfrestur17. nóvember 2024
Tungumálahæfni
Enska
Mjög góðNauðsyn
Staðsetning
Sæmundargata 15-19 15R, 101 Reykjavík
Starfstegund
Starfsgreinar
Starfsmerkingar
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