Manufacturing Engineer

CREGG; Galway; Hybrid; EUR 45,000 - 65,000; Full time

Job summary

CREGG in Galway seeks a Manufacturing Engineer to join a hybrid role supporting manufacturing projects in the medical device sector. You will work with manufacturing and quality teams on validation, documentation, and process improvements.

Ideal candidates have 2+ years in medical device manufacturing, experience with IQ/OQ/PQ, CAPA resolution, and strong technical writing skills. GMP understanding and cross-functional collaboration are essential for success.

Qualifications

• Degree in Engineering or Quality or related discipline.
• Experience in medical device/pharma manufacturing is desirable.
• Familiarity with IQ/OQ/PQ
• Strong technical writing and documentation abilities.
• Solid understanding of GMP and regulatory requirements.

Responsibilities

• Collaborate with manufacturing and cross-functional engineering teams to identify gaps and implement corrective actions for compliance.
• Execute equipment and process validation activities (IQ/OQ/PQ).
• Maintain quality system records and technical documentation for audit readiness.
• Coordinate with suppliers and vendors on NPI and procurement of equipment and materials.
• Lead CAPAs and NCRs closure with robust corrective actions.
• Develop clear SOPs and technical documentation for manufacturing processes.

Skills

Process validation

Technical writing

CAPA

Regulatory knowledge

GMP

Education

Engineering degree

Quality discipline

Job description

Manufacturing Engineer - Galway - (Hybrid role) - Medical Device

Our client, a global leader in medical device industry based in Galway, is looking for skilled Manufacturing Engineers to work in this Manufacturing Projects role.

This is an excellent opportunity to work and partner closely with manufacturing and quality teams to strengthen compliance and support process validation and NPI, process improvement projects.

Responsibilities

• Work alongside manufacturing engineers and cross funtional engineering teams to identify gaps and implement corrective actions to achieve compliance.


• Execute equipment and process validation activities (IQ/OQ/PQ).


• Revise and maintain quality system records and technical documentation to ensure audit readiness.


• Liaise with supplier sand vendors on NPI and procurement of equipment and materials.


• work on NPI projects - validating new processes and new equipment being introduced to site.


• Lead and support the closure of CAPAs and NCRs with robust corrective actions.


• Develop clear, accurate technical documentation and SOPs for quality and manufacturing processes.


• Lean Mfg advantageous - process improvement projects.


• Collaborate with cross-functional teams, including Manufacturing, Quality, and Regulatory, to deliver sustainable solutions.

Skills & Experience Required

• Degree in Engineering, Quality, or a related discipline.


• 2+ years of experience in medical device/pharma manufacturing, quality engineering desirable.


• background in process and/or equipment validation (IQ/OQ/PQ) and CAPA resolution.


• Excellent technical writing and documentation abilities.


• Solid understanding of regulatory requirements. with GMP and/or med device industry


• Strong problem-solving mindset, with the ability to collaborate with engineering teams.

NB* Candidates must hold a valid working visa for Ireland.