Alvotech hf
Alvotech hf
Alvotech hf

Process engineer F&F MSAT

Managing transition of new development processes into late stage-commercial manufacturing. Work as program team representative for technology transfer, validation activities and PPQ. Support external/CMO manufacturing activities.

Helstu verkefni og ábyrgð
  • Managing transition of new development processes into late stage-commercial manufacturing by working with PTM and subgroups.
  • Work as PTR with PTM and subgroups for technology transfer, validation activities and PPQ.
  • Support external/CMO manufacturing activities.
  • Responsible for quality documents during the batch (clinical/PPQ/commercial) i.e., process related deviations/change control/CAPA and OOS/OOT/OOR Phase II investigation.
  • Be an SME author of Deviations, CAPAs and change controls relating to DPM processes.
  • Be an SME author/reviewer and/or approver for written procedures, SOPs, protocols, comparability protocols, sample plan and reports etc.
  • Be an SME author for performing risk assessments relating to DPM processes.
  • Be an owner for continued process verification (CPV) activities for advanced commercial programs.
  • Responsible for addressing the regulatory queries and dossier review for new projects.
  • Ability of writing protocols and report the technical information in written and verbal format.
  • Basic knowledge of visual inspection guidelines and practices.
Menntunar- og hæfniskröfur
  • Education: A minimum of BSc in a technical discipline (e.g., pharmacy, biotechnology, biochemistry, engineering, or a related field) or MSc in a technical discipline (e.g., pharmacy, biotechnology, biochemistry, engineering, or a related field) preferred.
  • Experience: A minimum of 5-10 years industry experience in pharmaceutical development and/or manufacturing of finished dosage forms for biopharmaceuticals. Knowledge of GMP, Process Characterization and Validation.
  • Skills: Team player with strong leadership and organizational skills. Excellent written and verbal communication skills. Proficient in use of a PC and common Microsoft packages such as Word, Visio, 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