Production Specialist

4 days ago

Cork, Cork, Ireland beBeeProcess Full time €90,000 - €120,000
Process Engineer

We are seeking a Process Engineer to join our team in Cork, Ireland. As a global leader in the medical device industry, we offer exciting opportunities for growth and development.

This role involves supporting an upcoming project by focusing on manufacturing process validation, quality system updates, and documentation remediation. You will work closely with manufacturing and quality process owners to identify compliance gaps, implement corrective actions, and ensure documentation is accurate and audit-ready.

Main Responsibilities:

  • Analyse process, product, material or equipment specifications and performance requirements
  • Under broad supervision / guidance compile and analyse operational, test and experimental data to establish performance standards for newly implemented or modified products / processes
  • Summarise, analyse and draw conclusions from test results leading to effective technical resolution
  • Troubleshoot new products / process working closely with product development
  • Continually seek to drive improvements in process design, layout and operational performance
  • Demonstrate good working knowledge and application of validation techniques and associated regulatory requirements
  • Actively promotes and participates in a cross-functional teamwork environment
  • Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects
  • Understands and complies with all the regulations governing the quality systems

Key Requirements:

  • Engineering or Quality degree with 2-3 years' relevant industry experience
  • Background in remediation, process validation, CAPA, NCRs
  • Strong technical writing and documentation skills
  • Knowledge of 21 CFR Part 820, ISO 13485

Benefits Package:

  • Competitive compensation package
  • Pension contributions
  • Health insurance
  • Paid public holidays

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