Manufacturing Projects Engineer

CREGG; Galway; On-site; EUR 60,000 - 80,000; Full time

Job summary

CREGG is seeking a Manufacturing Projects Engineer for our Galway client, a leading medical device company. This hybrid role focuses on project leadership, process improvements, and GMP-compliant manufacturing support to drive quality, output and cost objectives.

The role requires NFQ Level 8 in a technical discipline and 2–5 years' engineering experience, preferably in regulated environments, with IQ/OQ/PQ validations. Collaboration with quality and engineering teams is essential.

Qualifications

• NFQ Level 8 in a technical discipline (Science, Biomedical, Mechanical, Manufacturing, etc.).
• 2-5 years’ experience at an engineering level, ideally in medical device or other highly regulated environments.
• Process & Equipment validations IQ/OQ/PQ.

Responsibilities

• Lead technical improvement under the VIP program.
• Lead process improvement programs across people, service, quality and cost dimensions.
• Liaison with quality and engineering both internal to the plant and externally within the corporation.
• Participation in phase review process and NPE meetings for new products.
• Ongoing manufacturing support to meet quality, output and cost objectives.
• Maintain a valid capacity model with the line Supervisor and plan for required capital.
• Provide leadership on Lean initiatives.
• Develop and implement GMP-compliant supporting documentation with the team.
• Project planning for major projects, product/process transfer, etc.
• Evaluate new equipment/processes/chemicals for environmental impact in collaboration with EHS.
• Other projects as assigned by the company.
• Understand and comply with all regulations governing quality systems.
• Develop themselves and team members.
• Manage delivery of capacity/sustaining projects focusing on quality, output and cost.

Skills

Project leadership

Process improvement

GMP awareness

Lean initiatives

Education

NFQ Level 8 in Technical Discipline

Tools

IQ/OQ/PQ validations

Job description

Manufacturing Projects Engineer – Galway (Hybrid)

About the role:

Our world leading Galway-based medical device client are now hiring experienced Manufacturing Engineers to join their Galway team. Hybrid role offering excellent career development. Successful candidates come from a strong project leadership/validation/equipment or medical device background.

Responsibilities:

• Leading technical improvement under the team’s VIP program.
• Lead process improvement programs across people, service, quality and cost dimensions.
• Liaison with quality and engineering both internal to the plant and externally within the corporation.
• Participation, where appropriate, in the phase review process and the NPE meetings with respect to new products.
• Ongoing manufacturing support in order to help the team meet its business objectives of quality, output and cost.
• Maintain a valid capacity model in co-operation with the line Supervisor and conduct adequate advance planning for required capital.
• Provide leadership on Lean initiatives.
• Development and implementation of appropriate supporting documentation, which complies with GMP in conjunction with the other team members.
• Project planning, in detail, in support of major projects, product/process transfer etc.
• Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
• Responsible for other projects as assigned by the company.
• Understandsand complieswith all the regulations governing the quality systems.
• Develop themselves and team members.
• Manage delivery of capacity/sustaining projects while focusing on quality, output and cost.

Qualifications and Experience:

• NFQ Level 8 in a Technical Discipline (Science, Biomedical, Mechanical, Manufacturing, etc.)
• Minimum 2-5 years’ experience working at an Engineering level,ideally in Medical Device industry or other highly regulated environment desirable.
• Process & Equipment validations IQ/OQ/PQ