Senior Validation Engineer
RK3957
12 Months
Dublin


We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


The 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.


Duties:

• 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 and Experience :

• Bachelor’s Degree in Engineering or Relevant Experience
• 6+ years experience in Engineering or Validation
• Extensive knowledge and demonstrated experience executing Validation activities for Pharmaceutical / Biotechnology projects
• Experience of sterile / biotech equipment within the pharmaceutical industry



If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.