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Process Simulation Technical Engineer
Reference: | SMC3795 | Location: |
Carlow |
Qualification: | Degree | Experience: | See description |
Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
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 [email protected] for further information.
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