Job Title: Process Engineer
Carlow, Ireland. Hybrid role with occasional shift work.
* Provide technical support for new product introduction (NPI) and commercial manufacturing.
* Participate in and/or lead cross-functional teams, including liaising with vendors or above-site groups.
Responsibilities:
* Design, author, review, approve, and execute qualification/validation documentation, process development studies, and change control.
* Contribute to Kaizen events as appropriate.
* Provide technical input into quality notifications by authoring, reviewing, and approving investigations.
* Execute equipment/qualification validation programs, including re-qualification and re-validation.
* Support continuous improvement through Lean Six Sigma methodologies.
* Perform root cause analysis of system failures and substandard performance using standard tools and methods to resolve machine and system issues.
Requirements:
* Bachelor's degree.
* 3 years of experience in a GMP environment, including process engineering experience.
* Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment (desirable).
* Equipment and process validation.
* Sterile filling processes and equipment.
* Demonstratable experience leading technical-related projects.