Direct message the job poster from Berkley GroupRecruitment Consultant - Life Science and Engineering at Berkley GroupCQV Engineer (Senior)Clean Utilities Commissioning and Qualification (C&Q) engineer for various capital projects. Ensure the C&Q activities associated with various capital projects are completed safely, as per schedule and in compliance with GMP and Quality Requirements.Responsibilities: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 Report)Provide 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).Basic Qualifications:6+ years experience in Engineering or Commissioning and Qualification ManagementTechnical qualification at third level or equivalent in Engineering.Extensive knowledge and demonstrated experience managing Commissioning and Qualification 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.Seniority levelMid-Senior levelEmployment typeContractJob functionConsulting, Engineering, and ManufacturingIndustriesPharmaceutical Manufacturing
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