The role:PE Global is currently recruiting for a Validation Engineer on behalf of a leading pharmaceutical company based in Carlow. This is a fixed term 11 month contract role.Overview:The successful candidates will support several aspects of Validation. The roles available that will require experienced, energetic and committed engineers are in the following areas:Isolator (Filling, Sterility & Material Transfer isolators) - HVAC, VHP, E-Beam and Depyrogenation systemsControlled Temperature Units (CTU) – Temperature/Humidity MappingFilter ValidationResponsibilities:Design/Author/Review/Approve/Execute qualification/validation documentation and cycle development studies in line with the standard approval process.Design/Author/Review/Approve/Execute Execution/development of change controls.Resolving technical issues encountered during study execution.Engagement with Production, Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.Technical input into quality notification by authoring/reviewing/approving investigations.Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.Support continuous improvement through Lean Six Sigma methodologies.Serve as validation representative for cross functional projects and represent the validation team at global technical forumsDrive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections and proactively highlighting any issues around complianceSupporting regulatory audits and submissions as required.Education and Experience:Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.Knowledge of CTU equipment qualificationKnowledge of thermal mapping equipmentThermal mapping skillsException / Deviation Management and Change Control.Demonstratable experience of leading technical related projects.Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirableEvidence of continuous professional development is desirable.Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.Ability to analyse and interpret complex data, and link to equipment performance and out of specification findings as appropriate.Report, standards, policy writing skills required.Equipment and process validation.Sterile Fill-Finish processes and equipment.Proficiency in Microsoft Office and job-related computer applications requiredExcellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.Knowledge that will be considered advantageousEquipment Periodic ValidationEquipment Validation LifecycleProject Management Skills/QualificationFilter Validation & Container Closure ValidationAutoclave/SIP Sterilisation ValidationDry Heat SterilisationIsolator QualificationVial and Syringe Processing TechnologiesTemperature MappingCleaning ValidationInterested 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***
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