C&Q Engineer (Clean Utilities)

Summary:

Our client is a biopharmaceutical company currently expanding its facility and is looking for a Clean Utilities C&Q Engineer who will own projects, equipment and be responsible for document drafting and protocol execution. The successful candidate will 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 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 Specifications (URSs) and Quality. Risk Assessment for Equipment and Automated Systems (QRAES). Qualifications & Experience: Technical qualification at third level or equivalent in Engineering. 6+ years' experience in Engineering or Commissioning and Qualification Management. Extensive knowledge and demonstrated experience managing Commissioning and Qualification for Pharmaceutical / Biotechnology projects preferred. Knowledge of safety, GMP and environmental regulatory requirements. Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry. Familiarity with paperless validation systems.
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