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Sean McCarthy
Life Science

+3530212339371
[email protected]
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Details

Process Engineer


Reference:SMC37595 Location: Carlow
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Bioprocess Engineer

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. 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

• Lead/execute production floor-based activities
• Participate on a team of engineers
• Plan and execute C&Q, validation activities as required
• Design & develop engineering studies
• Design/Author/Review/Approve/Execute process development studies in support of new product introduction and ongoing manufacturing support
• Provide technical input into quality notification by authoring/reviewing/approving investigations
• Execution of equipment/qualification validation programs; including re-qualification and revalidation
• Design/Author/Review/Approve/Execute 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
• Statistical data analysis to support development and commercialisation batches
• 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
• 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, 5 why’s etc
• Implement subsequent corrective action through the change management system
• Serve as technical engineering representative for internal technical group discussions and represent technical Operations Carlow at global technical forums
• Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups


Education & Experience

• Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other technical discipline
• Prior related work experience; ideally in manufacturing, preferably GMP Setting
• Typically have 5 years related work experience in Aseptic manufacturing / process engineering


If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.