Clean Utilities Commissioning and Qualification Engineer - DublinAre you a Clean Utilities Commissioning and Qualification Engineer with 6+ years of Extensive knowledge and demonstrated experience managing Commissioning andQualification for Pharmaceutical / Biotechnology projectst?This is a contract role based in Dun Laoghaire, Dublin.Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoghaire, South Dublin.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.Owns projects, equipment, responsible for document drafting and protocol executionClean Utilities Commissioning and Qualification (C&Q) engineer for various capital projects.
Ensure theC&Q activities associated with various capital projects are completed safely, as per schedule and in compliance with GMP and Quality Requirements.Commissioning & Qualification of Clean Utility Systems and execution of qualification documentationGeneration of all C&Q test documents (C&Q Plan/Set to Works/FAT/SAT/IV/FT/C&Q Summary ReportProvide technical assistance during investigations and system design.Coordinates and Supervises all C&Q activities on their systems.Ensures the C&Q schedule is maintained.Manages Daily C&Q coordination meetings.Responsible for Tracking and Reporting of C&Q status and risks/issues.Ensures Startup of equipment/utilities is completed in a safe and coordinated manner.Assist in the development of User Requirement Specifications (URS's) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).Requirements6+ years experience in Engineering or Commissioning and Qualification ManagementTechnical qualification at third level or equivalent in Engineering.Extensive knowledge and demonstrated experience managing Commissioning andQualification for Pharmaceutical / Biotechnology projects preferredKnowledge of safety, GMP and environmental regulatory requirements.Demonstrated strong Communication and Leadership skills.Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industryFamiliarity with paperless validation systems.PackageContract role - Hourly rate €60 - €70 per hourMinimum 12 month contract with the possibility of an extension.
Onsite expectations: 5 days per week
