CQV Engineer

2 days ago

Dublin, Dublin City, Ireland JobContax Full time

CQV Engineer - Dun Laoghaire, Dublin

Office/Project Location:Dun Laoghaire, Dublin

Employment Type: Contract

Work Location: Site Based

Pay: €60 - 70 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 Laoghaire, 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

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.

This role involves the management of tie-ins and IV executions during shutdown works.

It necessitates a well-rounded engineer with adaptability across systems and departments.

Execution of tasks such as ductwork movement, electrical cables management, and facility qualification

Integration of building expansions, including HVAC, clean utilities, and system networks

Involvement in FATs, SATs, and new WFI tank installation

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).

Execution of tasks such as ductwork movement, electrical cables management, and facility qualification

Integration of building expansions, including HVAC, clean utilities, and system networks

Involvement in FATs, SATs, and new WFI tank installation

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 Knowledge of safety, GMP and environmental regulatory requirements.

Execution of tasks such as ductwork movement, electrical cables management, and facility qualification

Integration of building expansions, including HVAC, clean utilities, and system networks

Involvement in FATs, SATs, and new WFI tank installation

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 - €70 per hour

Minimum 12 month contract with the strong possibility of an extension. 

Location: Fully onsite

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