Process Validation Specialist

2 weeks ago


Waterford, Waterford, Ireland beBeeValidation Full time €58,000 - €86,000
Process Validation Specialist Role

The Process Validation Specialist is responsible for ensuring that all manufacturing processes are validated to meet regulatory requirements.

Key Responsibilities:
  • Design and execute process validation studies for equipment, systems, and processes.
  • Develop and maintain validation documentation throughout the validation lifecycle.
  • Collaborate with cross-functional teams to ensure compliance with regulatory standards.
  • Provide technical guidance on current regulations and industry best practices.
  • Support site change control processes and participate in external regulatory inspections.
Requirements:
  • Degree in Science (Chemistry, Microbiology, or Pharmacy preferred) or Engineering.
  • 3-5 years of experience working in a healthcare manufacturing environment.
  • Ability to troubleshoot validation issues associated with projects and process development.
  • Knowledge of pharmaceutical plants and current process validation regulations.
  • Competent understanding of GAMP, ISPE Baseline guides, and steam and dry heat validation publications.


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