CQV Engineer, Dun Laoghaire, Dublin
Office/Project Location:Dun Laoghaire, Dublin
Employment Type: Contract
Work Location: On Site
Pay: €60 - €75 per hour
Experience: 5+ years
Visa: EU passport or Stamp 4 visa required
Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoighaire, South Dublin.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.
Owns projects, equipment, responsible for document drafting and protocol execution
Single Use / Formulation / 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.
Commissioning & Qualification of Single Use Systems / Formulation Equipment / 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)
Requirements
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
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.
Package
Contract role - Hourly rate €60 - €75 per hour
Minimum 12 month contract
Hybrid role