Senior Process Validation Engineer

1 week ago

Galway, Galway, Ireland beBeeManufacturing Full time €60,000 - €80,000
Manufacturing Engineer Opportunity

We are seeking a Manufacturing Engineer to support an upcoming project. This role will focus on manufacturing process validation, quality system updates, and documentation remediation.

Key Responsibilities:
  • Analyse process, product, material or equipment specifications and performance requirements.
  • 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 comply with all the regulations governing the quality systems.
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:
  • Competitive employee compensation package.
  • Pension contributions.
  • Health insurance.
  • Paid public holidays.
Location:

Galway, Ireland | onsite

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