Senior Technical Specialist

2 weeks ago

Sligo, Sligo, Ireland beBeeEngineering Full time €45,000 - €60,000
Graduate Engineer Job Description

We are seeking a highly motivated and detail-oriented Graduate Engineer to join our team at a EU GMP compliant vaccine manufacturing facility.

The ideal candidate will be involved in validation, qualification, and routine support of critical equipment and cleanroom environments. They will work closely with cross-functional teams (QA, Manufacturing, Maintenance) to ensure the highest standards of quality and compliance.

  • Key Responsibilities:
    • Temperature Mapping and Environmental Monitoring:
      • Plan, execute, and document temperature mapping studies for storage areas (cold rooms, freezers, incubators, warehouses) and critical process equipment.
      • Perform risk assessments to define mapping strategy and sensor placement.
      • Analyze data for compliance with EU GMP and internal quality standards.
    • Autoclave Load Qualification:
      • Support the qualification of autoclaves, including moist heat sterilization cycles.
      • Develop and execute load patterns and thermal distribution/equilibration studies.
      • Ensure Biological Indicators (BIs) and thermocouples are placed per GMP requirements.
      • Analyze cycle performance data and support requalification activities.
    • Equipment Qualification and Validation:
      • Assist with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new and existing equipment (e.g., HVAC, clean steam, washers, filling lines, isolators).
      • Support validation life cycle documentation and change control processes.
    • Cleanroom and Facility Support:
      • Support routine cleanroom qualification (HEPA integrity testing, airflow visualization, pressure differential monitoring).
      • Participate in periodic requalification and deviation investigations.
      • Assist in maintaining the state of control of classified environments.
    • Documentation and Compliance:
      • Prepare and review engineering documentation in compliance with EU GMP Annex 15, EMA, and FDA standards.
      • Completion of work orders in the engineering system.
      • Follow Good Documentation Practice (GDP) and support audit readiness.
      • Contribute to continuous improvement initiatives and deviation/CAPA investigations.

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