Get AI-powered advice on this job and more exclusive features.Direct message the job poster from PE GlobalSenior Recruitment Consultant @ PE GlobalThe role:PE Global is currently recruiting for a Senior Validation Engineer on behalf of a leading biotech company in Dublin South. This is an initial 12 month contract role.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.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 ValidationTechnical qualification at third level or equivalent in Engineering.Extensive knowledge and demonstrated experience executing Validation activities for Pharmaceutical / Biotechnology projectsExperience of sterile / biotech equipment within the pharmaceutical industry is preferred.Knowledge of safety and GMP requirements.Demonstrated strong Communication skillsExperience using Paperless Qualification Systems is preferred.Strong understanding of a risk-based approach to commissioning, qualification and validation within the biotechnology industryInterested candidates should submit an updated CV.Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***Seniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeContractJob functionIndustriesStaffing and RecruitingReferrals increase your chances of interviewing at PE Global by 2xSign in to set job alerts for “Validation Engineer” roles.Dublin, County Dublin, Ireland 3 days agoDublin, County Dublin, Ireland 6 days agoDublin, County Dublin, Ireland 2 days agoDublin, County Dublin, Ireland 3 days agoDublin, County Dublin, Ireland 2 weeks agoDublin, County Dublin, Ireland 4 days agoDublin, County Dublin, Ireland 1 month agoDublin, County Dublin, Ireland 1 week agoDublin, County Dublin, Ireland 6 days agoDublin, County Dublin, Ireland 3 days agoDublin, County Dublin, Ireland 1 week agoDublin, County Dublin, Ireland 4 days agoDublin, County Dublin, Ireland 2 days agoDublin, County Dublin, Ireland 2 weeks agoDublin, County Dublin, Ireland 2 days agoBray, County Wicklow, Ireland 3 weeks agoDublin, County Dublin, Ireland 3 days agoDublin, County Dublin, Ireland 1 week agoDublin, County Dublin, Ireland 2 weeks agoDublin, County Dublin, Ireland €60,000.00-€65,000.00 3 weeks agoDublin, County Dublin, Ireland 17 hours agoDublin, County Dublin, Ireland 2 weeks agoDublin, County Dublin, Ireland 3 days agoComputer Systems Validation & Compliance SpecialistCarmanhall and Leopardstown, Dún Laoghaire-Rathdown, Ireland 3 days agoDublin, County Dublin, Ireland 1 week agoProcess validation and change control managerDublin, County Dublin, Ireland 2 weeks agoQA Engineer I (6-month Maternity Leave Cover)Dublin, County Dublin, Ireland 4 weeks agoComputer Systems Validation & Compliance SpecialistCarmanhall and Leopardstown, Dún Laoghaire-Rathdown, Ireland 1 week agoDublin, County Dublin, Ireland 4 days agoDublin, County Dublin, Ireland 1 week agoWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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