OverviewGlobal Pharmaceutical company based in south Dublin, Ireland - looking for Snr. Validation Engineer.The successful candidate 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 roleGeneration, 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).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 Requirements Specifications (URS) and Quality Risk Assessments for Equipment and Automated Systems (QRAES).Qualifications6+ 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.The successful candidate must have eligible working VISA in Ireland or EU passport.Berkley Life Science & Engineering is a specialist consultancy recruiting professionals for organizations throughout Ireland, UK & Europe.If you would like to discuss this vacancy further or to discuss your career options in confidence, please contact the recruiter.
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