Process Engineer

Process Engineer

An established medical device manufacturer in Limerick is expanding its process engineering team due to sustained growth and new product introductions. This role will suit a hands-on Process Engineer who enjoys working in a highly regulated environment and wants real ownership of manufacturing processes rather than a purely documentation-led role.

What You'll Be Doing

• Own and improve manufacturing processes in a regulated cleanroom environment

• Lead and support process validation activities (IQ/OQ/PQ), including protocol authoring and execution

• Drive yield, scrap, and cycle-time improvements using structured problem-solving tools (Lean / Six Sigma / DOE)

• Support NPI and technology transfer projects from development into manufacturing

• Collaborate closely with Quality, Manufacturing, R&D and Automation teams

• Provide engineering support for deviations, CAPAs, change controls and audits (FDA, ISO 13485)

What We're Looking For

• Degree in Engineering (Mechanical, Biomedical, Manufacturing, Chemical or similar)

• Experience as a Process Engineer in a regulated manufacturing environment (medical devices strongly preferred; pharma/biotech also considered)

• Solid understanding of GMP, validation, and change control

• Comfortable working on the production floor as well as with documentation

• Someone who can challenge existing processes and drive practical improvements