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GMP Compliance Expert

1 week ago

Dublin, Dublin City, Ireland TN Ireland Full time

PSC Biotech is seeking a highly skilled Process Engineer to join our team at TN Ireland. As a key member of the Process Engineering Group, you will serve as technical support for new product introduction and commercial manufacturing.

You will have the opportunity to work with a diverse range of facilities and environments, including biological, chemical, automation, capital projects, maintenance, safety, process development, technical services, utilities, and validation.

Responsibilities
  • You will design and execute qualification/validation documentation and process development studies in line with the standard approval process.
  • You will contribute to Kaizen events and technical input into quality notifications by authoring, reviewing, and approving investigations.
  • You will support continuous improvement through Lean Six Sigma methodologies.
  • You will serve as a technical engineering representative for internal discussions and global forums.
Requirements
  • Bachelor's degree or higher preferred; ideally in a Science, Engineering, or Technical discipline.
  • Min 3 years' experience in manufacturing, preferably GMP Setting.
  • Demonstrable experience of leading technical-related projects.