Senior Biotechnology Validation Specialist

2 days ago

Dublin, Dublin City, Ireland beBeeValidation Full time €60,000 - €80,000

Job Title: Validation Engineer

Description: We are seeking a highly skilled professional to ensure that validation activities associated with a Syringe Filling Line for a Sterile fill finish facility comply with GMP and Quality Requirements.

Main Responsibilities:

  • Generation, execution, review and approval of CQV test documentation (FAT, IV's, FT's, SAT and PQ's) associated with a Syringe Filling Line.
  • Pre-approve and post-approve validation protocols.
  • Contribute to site validation master plans and standard operating procedures (SOP's).
  • 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.
  • Support the development of user requirement specifications (URS's) 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.
  • 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.

Benefits:

  • Hourly rate €60 - €80 per hour.
  • Minimum 12 month contract with the possibility of an extension.
  • Hybrid work arrangements may be possible at the outset.

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