Ms&T Process Engineer

2 weeks ago

Dublin, Ireland Quanta Consultancy Services Ltd Full time

OverviewMS&T Process Engineer - Ireland, Dublin - 11 Months Initial ContractDo you want to be involved with exciting pharmaceutical projects?When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than **** people.They are looking to add to their team and require a MS&T Process Engineer.ResponsibilitiesDemonstrated 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 ExperienceRelevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualificationExperience 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.If this role is of interest to you, please apply now#J-*****-Ljbffr

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