Manufacturing Projects Engineer

CREGG; Connacht; Hybrid; EUR 55,000 - 75,000; Full time

Job summary

Our Galway-based medical device client, supported by CREGG, is hiring a Manufacturing Projects Engineer for a hybrid role. You will lead VIP-driven improvement projects, coordinate across quality and engineering, and ensure GMP-compliant documentation to meet quality, output and cost targets.

Ideal candidates hold NFQ Level 8 in a technical discipline with 2–5 years’ engineering experience in regulated environments and a strong focus on project planning and validation (IQ/OQ/PQ).

Qualifications

• NFQ Level 8 in a technical discipline (science, biomedical, mechanical or manufacturing).
• 2–5 years’ experience at an engineering level, preferably in regulated environments.
• Experience with project planning/management and process validation IQ/OQ/PQ.

Responsibilities

• Lead manufacturing improvement projects under the VIP program.
• Drive process improvements across people, service, quality and cost.
• Collaborate with quality and engineering teams internally and externally.
• Participate in phase reviews and NPE meetings for new products.
• Provide ongoing manufacturing support to meet quality, output and cost goals.
• Maintain capacity models and plan for required capital upgrades.
• Provide leadership on Lean initiatives and GMP-compliant documentation.

Skills

Project management

Process validation

IQ/OQ/PQ

Manufacturing

GMP compliance

Education

NFQ Level 8 in a Technical Discipline

Job description

Manufacturing Projects Engineer

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.
• Responsible for other projects as assigned by the company.
• Understands and complies with 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.
• Project Planning/Management experience highly desirable.
• Process & Equipment validations IQ/OQ/PQ

INDTRAC