Alvotech hf
Alvotech hf
Alvotech hf

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
EnskaEnska
Nauðsyn
Mjög góð
Staðsetning
Sæmundargata 15-19 15R, 101 Reykjavík
Starfstegund
Starfsgreinar
Starfsmerkingar