MS&T Process Engineer

24 hours ago

Dublin, Dublin City, Ireland QCS Staffing Full time
Overview

MS&T Process Engineer - Ireland, Dublin - 11 Months Initial Contract. Do you want to be involved with exciting pharmaceutical projects? Our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence, employing more than 1000 people. They are looking to add to their team and require an MS&T Process Engineer.

Responsibilities
  • Demonstrated leadership and change management skills with a continuous improvement focus.
  • Proven track record of delivering high performance through development and coaching of a team.
  • Evidence of continuous professional development.
  • Strong collaboration to promote knowledge sharing and implementation of best practices across the site.
  • SME in upstream/downstream processing and process control strategies. Working knowledge of analytics.
  • Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment.
Desirable Experience / Qualifications
  • Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification
  • Experience leading technical related projects.
  • Experience with upstream cell culture and/or downstream purification of biological molecules.
  • Experience in preparing for and presenting in front of regulatory audits as SME.
  • Experience with technology transfer, regulatory filing and commercial drug substance manufacturing of biologics is a plus.
  • Technical operations experience in the drug substance manufacture of biological molecules at commercial-scale.
  • Prior 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.
  • Experience in change management, deviations and CAPAs management.
Employment Details
  • Seniority level: Mid-Senior level
  • Employment type: Contract
  • Job function: Management and Manufacturing

Location: Dublin, County Dublin, Ireland


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