GMP Manufacturing Expert

4 days ago


The Municipal District of Carlow, Ireland RT Full time

A career opportunity has arisen for a skilled Process Engineer to join the Process Engineering Group on site and report to the Technical Engineering Manager.

The successful candidate will provide technical support for new product introduction (NPI) and commercial manufacturing, participating in or leading cross-functional or single-function teams.

Responsibilities will include:

  • Design, authoring, reviewing, approving, and executing qualification/validation documentation and process development studies.
  • Designing, authoring, reviewing, approving, and executing change controls.
  • Contribution to Kaizen events, providing technical input into quality notifications, and supporting continuous improvement through Lean Six Sigma methodologies.

Key Requirements:

  • Bachelor's Degree or higher preferred in a Science, Engineering, or other technical discipline.
  • Minimum 3 years' experience ideally in manufacturing, preferably in a GMP setting.
  • Demonstrable experience of leading technical-related projects.
  • Knowledge of regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices.
  • Report, standards, and policy writing skills required.
  • Equipment and process validation experience.
  • Sterile filling processes and equipment knowledge.
  • Proficiency in Microsoft Office and job-related computer applications required.
  • Excellent communication, presentation, and interpersonal skills to interface effectively with all levels of colleagues and with external customers in a team-oriented manner.


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