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Validation Engineer Position

2 weeks ago

Galway, Galway, Ireland beBee Careers Full time

**Key Responsibilities:**

  • The Contract Validation Engineer will develop, execute, and review Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for sterile manufacturing equipment.
  • The successful candidate will ensure compliance with cGMP, FDA, EMA, and Annex 1 requirements for validation activities.
  • A key responsibility of this role will be to perform risk assessments (e.g., FMEA) to determine validation strategies and critical parameters.
  • The Contract Validation Engineer will maintain the validated state of manufacturing equipment, clean utilities, and process support systems.
  • This role will involve qualifying and validating aseptic filling lines, lyophilizers, autoclaves, depyrogenation tunnels, and isolator/RABS systems.
  • The successful candidate will also support clean utilities qualification (e.g., WFI, clean steam, compressed air, HVAC).
  • In addition, the Contract Validation Engineer will ensure validation of automation and control systems (SCADA, PLC, MES) where applicable.
  • The Contract Validation Engineer will also support audits and regulatory inspections by providing validation data and technical justifications.
  • Other responsibilities include ensuring adherence to Annex 1, ICH Q9 (Risk Management), ICH Q10 (Quality Systems), and FDA Process Validation Guidance.