Senior Project Engineer

Senior Project Engineer – Limerick

We are currently recruiting for an experienced Senior Project Engineer to join a leading manufacturing organisation based in Limerick.

This is a fully onsite, days-based position, working on equipment, process improvement and engineering projects within a highly regulated manufacturing environment.

The Role

You will be responsible for delivering small to medium-scale engineering projects involving both new and existing manufacturing equipment and processes.

Key responsibilities will include:

• Manage engineering projects from initial concept through implementation and handover.
• Develop equipment and process requirements, specifications and URS documentation.
• Provide technical engineering support for new and existing manufacturing equipment.
• Support the selection, specification and introduction of new equipment and technologies.
• Coordinate with equipment suppliers and external vendors.
• Develop and execute equipment and process validation activities.
• Identify and implement improvements to equipment efficiency, reliability, yield and throughput.
• Troubleshoot equipment and process issues and support root-cause investigations.
• Support CAPA, non-conformance and quality system activities.
• Ensure engineering projects meet relevant safety, environmental and quality requirements.
• Work closely with Manufacturing, Quality, Validation, Maintenance and other cross-functional teams.

Requirements

• Degree in Mechanical, Manufacturing, Production Engineering or a related engineering discipline.
• Minimum 3 years’ experience in a Manufacturing Engineer, Project Engineer or similar position.
• Experience working within a GMP-regulated manufacturing environment.
• Strong experience delivering equipment and/or process-related engineering projects.
• Good project management, problem-solving and communication skills.
• Ability to work independently while contributing effectively within cross-functional teams.

Advantageous

• Experience within medical device or other highly regulated manufacturing environments.
• Equipment and process validation experience.
• Process development and continuous improvement experience.
• Knowledge of ISO safety standards.
• Experience with SPC, DOE, ANOVA or statistical process analysis.
• Familiarity with FDA-regulated equipment validation.