Senior Manufacturing Engineer - Lean Ops & Validation

Morgan McKinley; Galway; On-site; EUR 52,000 - 76,000; Full time

Job summary

Morgan McKinley is seeking an engineering professional to provide daily technical and operational support across products, processes, and equipment to drive unit performance. The role emphasizes GMP and ISO compliance, patient safety, and cross-functional collaboration with EHS, Quality and corporate Engineering.

You will oversee equipment installation, process validation (OQ/PQ) and maintain compliant technical documentation, while managing sustaining and capacity projects across sites and

Qualifications

• Education: Level 8 Degree in Engineering or a relevant discipline.
• Experience: Minimum 2 years in an engineering role within Medical Devices or a similar regulated industry.
• Core competencies: Strong grounding in equipment qualification, process validation (OQ/PQ), and systematic problem-solving.
• Systems & tools: Familiarity with MES, SAP, or PLM systems (e.g., Windchill) is a strong plus.

Responsibilities

• Technical Leadership: Lead process improvements, technical troubleshooting, and Lean initiatives to optimize quality, throughput, and unit costs.
• Compliance & Quality: Maintain strict compliance with GMP, ISO standards, and quality system regulations while keeping patient safety as the top priority.
• Validation & Engineering: Oversee equipment installation, process validation (OQ/PQ), and the creation of compliant technical documentation.
• Project & Capacity Management: Plan and execute sustaining and capacity projects across sites, maintaining capacity models and advance planning for capital requirements.
• Cross-Functional Collaboration: Partner with EHS, Quality, and corporate Engineering teams, supporting new product introductions (NPE) and environmental impact assessments.

Skills

Technical leadership

Process improvement

Lean initiatives

Compliance & quality mindset

Project management

Education

Engineering degree (Level 8)

Tools

MES

SAP

Windchill (PLM)

Job description

Morgan McKinley is seeking an engineering professional to provide daily technical and operational support across products, processes, and equipment to drive unit performance. The role emphasizes GMP and ISO compliance, patient safety, and cross-functional collaboration with EHS, Quality and corporate Engineering.

You will oversee equipment installation, process validation (OQ/PQ) and maintain compliant technical documentation, while managing sustaining and capacity projects across sites and