Manufacturing Engineer

CREGG; Galway; Hybrid; Confidential; Full time

Job summary

CREGG is seeking a Manufacturing Engineer for Galway in a hybrid role within the medical device sector. The position focuses on partnering with manufacturing and quality teams to support process validation, NPI and continuous improvement, ensuring compliance and robust technical documentation.

You will work with cross-functional teams to drive CAPA resolutions, SOPs, and lean manufacturing initiatives while maintaining audit readiness and collaborating on supplier and regulatory interfaces.

Qualifications

• Degree in Engineering or related discipline.
• 2+ years of experience in medical device/pharma manufacturing.
• Background in IQ/OQ/PQ validation and CAPA resolution.
• Excellent technical writing and documentation abilities.
• Solid understanding of GMP/med device regulatory requirements.
• Strong problem-solving mindset and cross-functional collaboration.

Responsibilities

• Collaborate with manufacturing and cross-functional teams to close gaps and drive compliance.
• Execute IQ/OQ/PQ validation activities and support NPIs.
• Revise and maintain quality records and technical documentation for audit readiness.
• Liaise with suppliers and vendors on NPI and equipment procurement.
• Lead CAPA and NCR closures with robust corrective actions.
• Develop clear SOPs and manufacturing process documentation.
• Support lean manufacturing and process improvement projects.
• Coordinate with Manufacturing, Quality, and Regulatory to deliver sustainable solutions.

Skills

Process validation

CAPA resolution

Technical writing

Cross-functional collaboration

Regulatory knowledge GMP

Lean manufacturing

Education

Engineering degree

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.