Advanced Manufacturing Specialist

6 days ago

Carlow, Ireland beBeeProcessEngineer Full time €55,000 - €80,000
Process Engineer Role

We are seeking an experienced professional to join a leading organization in Carlow. This role offers an excellent opportunity for someone looking to work with a multinational company at the forefront of their industry.

  • Key Responsibilities:
  • Develop and implement qualification/validation documentation and process development studies in line with standard approval processes.
  • Create, review, and execute change controls to ensure seamless operations.
  • Contribute to continuous improvement initiatives.
  • Provide technical input into quality notifications by authoring, reviewing, and approving investigations.
  • Execute equipment/qualification validation programs, including re-qualification and re-validation.
  • SUPPORT ongoing improvement through Lean Six Sigma methodologies.
  • Analyze system failures and substandard performance using standard tools and methods to resolve machine and system issues.
  • Represent the engineering team in internal discussions and global technical forums.
  • Ensure compliance with Global Policies, Procedures, and Guidelines, regulatory requirements, and cGMP principles in day-to-day activities and job functions.
  • Work collaboratively to foster a safe and compliant culture.
  • Perform other duties as assigned.
Requirements
  • Bachelor's Degree or higher in a Science, Engineering, or Technical discipline preferred.
  • A minimum of 3 years' experience in manufacturing, preferably in a GMP setting.
  • Demonstrated experience leading technical projects.
  • Evidence of continuous professional development is desirable.
  • Familiarity with process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment is beneficial but not essential.

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