34379-Clean Utilities-C&Q Engineer-Dublin Contractor

This is a 12 month contract with a view to extension.

Purpose:

Owns projects, equipment, responsible for document drafting and protocol execution.

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 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 (URS’s) and Quality

Risk Assessment for Equipment and Automated Systems (QRAES).

Requirements:

• 6+ years experience in Engineering or Commissioning and Qualification Management

• 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.