Senior Validation Engineer

Senior Validation Engineer RK3957 12 Months Dublin Were 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 (IVs), Functional Testing (FTs), Site Acceptance Testing (SAT) and Performance Qualifications (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. 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 (URSs) and Quality Risk Assessment for Equipment and Automated Systems (QRAES) Education and Experience : Bachelors 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. Skills: Validation Vial or Syringe Filling lines GMP