Pharmaceutical Process Development Engineer

5 days ago

Dublin, Dublin City, Ireland beBeeProcess Full time €72,000 - €96,000
Process Engineer Job Overview

We are seeking a highly skilled Process Engineer to join our team in Dublin, Ireland. This is a fantastic opportunity to be involved in exciting projects and work with a Centre of Excellence that employs over 1000 people.

Key Responsibilities
  • Lead and manage teams with a focus on continuous improvement.
  • Develop and coach high-performing teams to deliver exceptional results.
  • Stay up-to-date with the latest developments in your field through ongoing professional development.
  • Collaborate with colleagues to share knowledge and best practices.
  • Be a subject matter expert in upstream/downstream processing and process control strategies, with a working knowledge of analytics.
  • Have experience with process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment.
Required Skills and Qualifications
  • Possess relevant technical qualifications in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.
  • Have experience leading technical projects.
  • Have experience with upstream cell culture and/or downstream purification of biological molecules.
  • Be able to prepare for and present during regulatory audits as a subject matter expert.
  • Have experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics.
  • Have technical operations experience in the drug substance manufacture of biological molecules at commercial-scale.
  • Have experience in drug substance process development, process characterisation studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory CTD sections, and/or working with external contract organisation for development and/or manufacturing.
  • Have experience in change management, deviations, and CAPAs management.

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