Data Validation Specialist

2 weeks ago


Waterford, Waterford, Ireland beBeeValidation Full time €40,000 - €80,000
Job Summary

We are seeking a skilled Data Validation Specialist to join our team. As a CSV Engineer, you will be responsible for ensuring the validation and compliance of computerized equipment and systems in sterile pharmaceutical manufacturing environments.

Key Responsibilities:
  • Develop and execute validation protocols (DQ, IQ, OQ, PQ) for computerized equipment and control systems.
  • Generate and review validation documentation, including protocols, reports, and revalidation plans.
  • Provide technical expertise on current FDA and EU validation requirements, particularly for lyophilization, aseptic processing, and sterilization.
  • Participate in the change control process, advising on CSV-related matters.
  • Ensure compliance with cGMP, health, safety, and environmental regulations.
  • Troubleshoot validation issues and provide solutions during project execution.
  • Review and approve site change controls and ensure validation status aligns with regulatory expectations.
  • Collaborate with cross-functional teams to ensure project timelines and quality standards are met.
Requirements

To succeed in this role, you will need:

  • A degree in Science (e.g., Chemistry, Microbiology, Pharmacy) or Engineering (e.g., Chemical, Mechanical, Electrical).
  • A strong understanding of GAMP, ISPE Baseline Guides, and quality management systems.
  • Hands-on experience in validation activities within a healthcare or pharmaceutical manufacturing environment.
  • Knowledge of cGMP regulations and compliance requirements.
  • Effective communication and facilitation skills across teams and organizational levels.
  • The ability to manage projects effectively and meet key performance indicators (KPIs).
  • A problem-solving mindset with adaptability and resilience.


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