Snr Cqv Engineer

Description:

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.

Filling Line experience Desirable

Key Responsibilities:

• URS, risk assessments, FAT support, FAT protocol reviews, FAT wrappers, IVs, FVs, SATs, summary reports etc prep and execution.
• 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 (URS’s) and Quality
• Risk Assessment for Equipment and Automated Systems (QRAES).

Education / Experience:

• Technical qualification at third level or equivalent in Engineering.

• Extensive knowledge and demonstrated experience managing Commissioning and

Qualification 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 qualification

within the biotechnology industry

• Familiarity with paperless validation systems.