Senior Engineer

5 days ago

Waterford, Waterford, Ireland beBeePharmaceutical Full time €60,000 - €80,000
Process Plant Validation Expert

We are seeking a highly skilled process plant engineer to join our team in Waterford. The ideal candidate will have a strong background in validation and compliance, with experience working in a healthcare manufacturing environment.

Key Responsibilities:
  • Executing Factory Acceptance Testing/ Site Acceptance Testing/ Installation Qualification protocols and generating reports
  • Designing and executing validation studies for equipment, systems, and processes
  • Maintaining validation documentation throughout the validation lifecycle
  • Providing technical interpretation and guidance on US FDA and EU validation requirements
  • Participating in external regulatory inspections and supporting site change control process
Requirements:
  • Degree in Science (Chemistry, Microbiology or Pharmacy preferred) or Engineering Chemical/Mechanical/Electrical)
  • 3-5 years experience working in a Healthcare manufacturing environment, preferably in the pharmaceutical sector
  • Competent technical knowledge of pharmaceutical plants and previous validation/product development experience
  • Knowledge of Process Validation regulations, industry practices, and guidelines

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