We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

• Design/Author/Review/Approve/Execute process simulations studies in support of new product introduction and ongoing manufacturing support.

• Provide technical input into quality notification by authoring/reviewing/approving Process Simulation related investigations.

• Design/Author/Review/Approve/Execute process simulation qualification/validation documentation and studies in line with the standard approval process

• Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis

• Support continuous improvement through Lean Six Sigma methodologies.

• Leading and active participation in projects, system failure investigations and investigation reports,

• Execution/development of change controls to support the Process Simulation process

• Contribution to Kaizen events as appropriate.

• Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams,why’s etc.;

• Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.


Education & Experience

• Operations experience in a sterile manufacturing environment, preferably with Aseptic Process Simulations execution.

• Equipment and process validation

• Sterile filling processes and equipment


If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or sean.mccarthy@lifescience.ie for further information.