System Integrity Expert

1 day ago

Dublin, Dublin City, Ireland beBeeValidation Full time €80,000 - €110,000
Computer Systems Validation Specialist

We are seeking an experienced professional to join our team as a Computer Systems Validation Specialist. This role will focus on ensuring the integrity and security of critical systems in sterile drug product manufacturing.

About the Role

The ideal candidate will have a strong background in computer system validation, with experience working in regulated industries such as pharmaceuticals or biotechnology. They will be responsible for developing and executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for various computer systems and software applications.

  • Develop and execute comprehensive validation plans, including test scripts, traceability matrices, and validation summary reports.
  • Work collaboratively with cross-functional teams to ensure adherence to regulatory guidelines and internal policies.
  • Conduct risk assessments and impact analyses to identify critical system functionalities and potential vulnerabilities.
  • Stay up-to-date with industry trends, regulatory changes, and advancements in computer system validation.
Requirements

To be successful in this role, the candidate must possess:

  • Bachelor's degree in Computer Science, Engineering, or a related field.
  • 5+ years of experience in computer system validation within a regulated industry.
  • Strong knowledge of regulatory guidelines, including FDA 21 CFR Part 11 and EU Annex 11.
  • Familiarity with various validation methodologies, including risk-based approaches.
Benefits

This role offers a unique opportunity to work in a dynamic environment and contribute to the success of our organization.

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