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