LSC are currently looking for a Process Engineer to lead Inspection NPI activities. The Process Engineer will be based in site with our multinational Biopharmaceutical client in south Dublin.
The Process Engineers responsibilities will be:
oLeads Inspection NPI activities from a Process Development perspective and serves as the Process Development Inspection SME.
oActs as an inspection technical expert to provide solutions when troubleshooting inspection issues through the NPI or post-NPI phases.
oInterfaces with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing.
oTroubleshoots issues with inspection equipment.
oConducts risk assessment for inspection operations and propose / implement appropriate CAPA.
oIdentifies and implements operational opportunities for current and new inspection operations.
oResponsibilities may include leading cross-site teams to support the above activities, providing recommendations to management.
oDevelopment of Validation Plans, IOQs and PQs
The Process Engineer requires:
o5 + years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Process Characterization, Tech Transfer (to commercial DP sites) or Validation.
oStrong skills in applying fundamental engineering and scientific principles to the design and implementation of Inspection processes
oProject management skills including the ability to manage multiple projects and evaluate project resource requirements.
oStrong knowledge of Quality systems, Drug Product Inspection and Validation.
Call James in LSC for more details, 021-4777329 or apply directly through this advert.