Process Simulation Expert

3 days ago

Carlow, Ireland beBeeProcessSimulation Full time €80,000 - €100,000
Process Simulation Technical Engineer

We are currently seeking an experienced Process Simulation Technical Engineer to provide technical support for process simulation development and execution. The ideal candidate will have 3-5 years experience in a sterile manufacturing environment, preferably with Aseptic Process Simulations execution.

Key Responsibilities:

  • Design/author/review/approve/execute process simulations studies in support of new product introduction and ongoing manufacturing support.
  • Provide technical input into quality notifications by authorizing/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, 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 at global technical forums in relation to process simulations.
  • Participate and/or lead cross-functional or single-function teams including liaising with vendors or above-site groups.
  • Drive compliance of policies, procedures, and guidelines, regulatory requirements, and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
  • Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections, and proactively highlighting any issues around compliance.
  • Work collaboratively to drive a safe and compliant culture.
  • May be required to perform other duties as assigned.

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