CQV Engineer Dublin

Desired Skills: CQV Engineer,Biologics,Utilities

PE Global is currently recruiting for a CQV Engineer for a leading biologics client based in Dublin.

This is an initial 12-month contract position.

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

Overview:

Clean Utilities/ Facilities / Equipment Commissioning and Qualification (C&Q) engineer for a capital project. Ensure the C&Q activities associated with the capital project are completed safely, as per schedule and in compliance with GMP and Quality Requirements.

Key Responsibilities:

• Commissioning & Qualification of Clean Utility Systems / Facility and Process equipment.
• 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:

• 3+ 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
• Strong understanding of a risk‐based approach to commissioning and qualification
• within the biotechnology industry
• Familiarity with paperless validation systems.

Please click the link below to apply, or alternatively send an up-to-date CV to rebecca@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***