Validation Specialist

4 days ago

Dublin, Dublin City, Ireland beBeeValidation Full time €90,000 - €108,000

We are seeking an experienced Validation Engineer to join our team.

Job Description:

The successful candidate will be responsible for ensuring the quality and reliability of our medicines by executing validation activities associated with a Syringe Filling Line for a Sterile fill finish facility. This will involve generating, executing, reviewing, and approving CQV test documentation (FAT, IVs, FTs, SAT, and PQs).

As a key member of our team, you will play a critical role in ensuring compliance with GMP and Quality Requirements. Your extensive knowledge and experience in executing validation activities for Pharmaceutical/Biotechnology projects will be invaluable in this position.

Key Responsibilities:
  • Ensure validation activities for the Syringe Filling Line are compliant with GMP and Quality Requirements.
  • Generate, execute, review, and approve CQV test documentation (FAT, IVs, FTs, SAT, and PQs).
  • Pre-approve and post-approve validation protocols.
  • Collate and report on relevant validation data/metrics.

You will also assist in exceptions and deviation resolution and root cause analysis. Additionally, you will review and approve Qualification summary reports (QSR) and Generate Validation Summary reports.

Requirements:
  • 6+ years experience in Engineering or Validation.
  • Technical qualification at third level or equivalent in Engineering.
  • Extensive knowledge and demonstrated experience executing Validation activities for Pharmaceutical/Biotechnology projects.
  • Experience of sterile/biotech equipment within the pharmaceutical industry is preferred.
  • Knowledge of safety and GMP requirements.
  • Demonstrated strong Communication skills.
  • Experience using Paperless Qualification Systems is preferred.
  • Strong understanding of a risk-based approach to commissioning, qualification, and validation within the biotechnology industry.

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