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.