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.