Validation EngineerAny additional information you require for this job can be found in the below text Make sure to read thoroughly, then apply.
- Hybrid RK25602 Contract 11 months Carlow Were currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Carlow.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.Key Responsibilities: 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 forums Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (c GMP) 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 compliance Supporting regulatory audits and submissions as required.Education and Experience: 3-5 years direct experience with a pharmaceutical or biotechnology company with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification Knowledge of process monitoring systems, automation systems (Delta V), operational intelligence & data systems (Pi System) within a GMP manufacturing Knowledge of CTU equipment qualification and thermal mapping equipment Experience with equipment and process validation, sterile fill-finish processes and equipment.
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