Senior Validation Specialist

1 week ago

Dublin, Dublin City, Ireland beBeeValidation Full time €55,000 - €85,000
Job Summary

We are seeking a Validation Engineer to join our team. In this role, you will be responsible for ensuring that the Validation activities associated with a Syringe Filling Line for a Sterile fill finish facility are in compliance with GMP and Quality Requirements.

The successful candidate will have extensive knowledge and demonstrated experience executing Validation activities for Pharmaceutical / Biotechnology projects.

Key Responsibilities
  • Generation, execution, review and approval of CQV test Documentation (FAT, IVs, FT, SAT and PQs) associated with a Syringe Filling Line.
  • Pre-Approve and Post-Approve validation protocols.
  • Input into site Validation Master Plans and Standard Operating Procedures (SOPs).
  • Collate and report on relevant validation data/metrics.
  • Assist in exceptions and deviation resolution and root cause analysis.
  • Review Validation planning documents detailing overall strategy for the project.
  • Review and Approve Qualification summary reports (QSR).
  • Generate Validation Summary reports.
  • Assist in the development of User Requirement Specifications (URS) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).
Requirements
  • 6+ years experience in Engineering or Validation.
  • Technical qualification at third level or equivalent in Engineering.
  • 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.
Preferred Qualifications
  • Experience of sterile / biotech equipment within the pharmaceutical industry.
  • Knowledge of safety and GMP requirements.
Seniority level
  • Mid-Senior level
Employment type
  • Contract
Job function
  • Engineering and Science
Industries
  • Pharmaceutical Manufacturing

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