Chief Manufacturing Process Developer

5 days ago


Galway, Galway, Ireland beBeeManufacturingEngineer Full time €90,000 - €110,000

Job Overview:

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We are seeking a skilled Manufacturing Engineer to partner closely with our manufacturing and quality teams to strengthen compliance and support process validation projects.

About the Role:

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  • Work alongside manufacturing owners to identify gaps and implement corrective actions to achieve compliance.
  • Contribute to equipment and process validation activities (IQ/OQ/PQ).
  • Revise and maintain quality system records and technical documentation to ensure audit readiness.
  • 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.

Requirements:

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  • Degree in Engineering, Quality, or a related discipline.
  • 2–5 years of experience in medical device manufacturing, quality engineering, or remediation work.
  • Strong background in process validation (IQ/OQ/PQ) and CAPA/NCR resolution.
  • Excellent technical writing and documentation abilities.
  • Solid understanding of 21 CFR Part 820 and ISO 13485 requirements.
  • Strong problem-solving mindset, with the ability to drive issues to fully compliant solutions.

What We Offer:

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A challenging opportunity to develop your skills and expertise in a collaborative environment.

Key Skills and Qualifications:

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Manufacturing Engineer



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