Job Description
Purpose Clean Utilities Commissioning and Quali?cation (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 & Quali?cation of Clean Utility Systems and execution of quali?cation documentation Generation 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 Speci?cations (URSs) and Quality Risk Assessment for Equipment and Automated Systems (QRAES). Requirements 6+ years experience in Engineering or Commissioning and Quali?cation Management Technical quali?cation at third level or equivalent in Engineering. Extensive knowledge and demonstrated experience managing Commissioning and Quali?cation for Pharmaceutical / Biotechnology projects preferred Knowledge 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 quali?cation within the biotechnology industry Familiarity with paperless validation systems. Skills: Clean Utilities C&Q Test Documents Risk Assessments Capital Projects