Validation Engineer

3 weeks ago

Dublin, Dublin City, Ireland DPS Group Global Full time

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Direct message the job poster from DPS Group Global

Recruitment Specialist @ Arcadis DPS Group

Overview:

Validation Engineer 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.

Key Responsibilities:

  • Generation, execution, review and approval of CQV test Documentation (Factor Acceptance Testing (FAT), Instillation Verification (IV's), Functional Testing (FT's), Site Acceptance Testing (SAT) and Performance Qualifications (PQ's) associated with a Syringe Filling Line.
  • Pre-Approve and Post-Approve validation protocols.
  • Input into 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.
  • Reviews Validation planning documents detailing overall strategy for the project.
  • Reviews and Approves Qualification summary reports (QSR)
  • Generates Validation Summary reports.
  • Assist in the development of User Requirement Specifications (URS's) and Quality Risk Assessment for Equipment and Automated Systems (QRAES)

Education / Experience:

  • 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

Top Skills:

  • Extensive knowledge and demonstrated experience managing Validation activities for Pharmaceutical / Biotechnology projects
  • Experience of sterile / biotech equipment within the pharmaceutical industry is preferred
  • Experience of aseptic processing
  • Experience in GMP
Seniority level
  • Seniority levelMid-Senior level
Employment type
  • Employment typeFull-time
Job function
  • Job functionEngineering, Science, and Quality Assurance
  • IndustriesEngineering Services, Pharmaceutical Manufacturing, and Biotechnology Research

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