C&Q Inspection Engineer

1 day ago


Dublin, Ireland Cpl Healthcare Full time

Company ProfileOur client is a leading multinational biopharmaceutical organization based in Dublin and they are hiring for a C&Q Inspection Engineer on an initial 12-month contract.The role will be based at a highly modernised site with cutting-edge equipment and an exciting new project to aid delivery.If you have a background in CQV relating to inspection equipment and are looking for your next contract, please reach out todayKey ResponsibilitiesDevelopment and execution of CQV testing documentation for inspection systems including syringe and vial automated visual inspection equipment and manual inspection booths for the sterile drug product facility.Responsible for meeting key project deliverables for safety, CQV schedule and quality of project-related documentation and electronic records for equipment and utilities.Ensure GMP equipment are tested in compliance with good manufacturing practices, company policies and EU & FDA regulations.Ensure all inspection equipment is tested in compliance with project-related standards from a commissioning perspective.Manage deviations associated with the assigned equipment and utilities.Risk management – identify and categorise CQV risks according to impact on commissioning and qualification; generate action plans to mitigate qualification risks.Execute FAT testing and leverage results into overall qualification process for assigned equipment, facilities and utilities.Ensure all assigned training is executed on time to meet site metrics.Essential RequirementsMinimum of a BS qualification (degree) in a scientific, technical or engineering discipline with at least 5 years of experience within the pharmaceutical industry, ideally with familiarity with sterile drug product filling line experience.Demonstratable capacity to effectively execute the CQV testing approach for assigned projects from initiation to completion.CQV project lifecycle experience from design through to C&Q and handover.Demonstrable experience performing as part of a diverse team of CQV professionals/contractors to deliver tasks safely, with a quality focus, on time and within budget.Experience in CQV of drug substance/drug product sterile manufacturing equipment with integrated automation.Experience in leading, managing and executing FAT activities.Solid background in document preparation, execution and task planning on CQV projects with a demonstrated record of on-time performance.Excellent communication skills and the ability to influence others.Demonstrable experience working in teams in a matrix environment to deliver CQV elements.Previous experience with electronic validation platforms ValGenesis or Kneat.#J-*****-Ljbffr



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