CSV Validation Specialist

1 week ago

Waterford, Waterford, Ireland beBeeValidation Full time €91,234 - €123,456

Unlocking Impact through Engineering Excellence

As a CSV Engineer, you will play a pivotal role in ensuring the validation and compliance of computerized equipment and systems in sterile pharmaceutical manufacturing environments. This is an opportunity to leverage your engineering expertise to drive meaningful impact.

  • Develop and execute comprehensive validation protocols (DQ, IQ, OQ, PQ) for computerized equipment and control systems, upholding regulatory and quality standards.
  • Create and review validation documentation, including protocols, reports, and revalidation plans, to ensure accuracy and completeness.
  • Provide technical guidance on FDA and EU validation requirements, particularly for lyophilization, aseptic processing, and sterilization, staying abreast of industry developments.
  • Participate in change control processes, offering expert insights on CSV-related matters and ensuring compliance with cGMP, health, safety, and environmental regulations.
  • Troubleshoot validation issues, providing timely solutions during project execution, and collaborate with cross-functional teams to meet project timelines and quality standards.

Key Requirements:

  • Bachelor's Degree in Science or Engineering.
  • Strong understanding of GAMP, ISPE Baseline Guides, and quality management systems.

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