Clean Utilities Commissioning and Qualification Engineer

2 weeks ago


Dublin, Dublin City, Ireland JobContax Full time

Clean Utilities Commissioning and Qualification Engineer - Dun Laoghaire, Dublin

Office/Project Location: Dun Laoghaire, Dublin

Employment Type: Contract

Work Location:   Site Based

Pay:  €60 - €70 per hour

Experience: 6 + years

Visa:  EU passport or Stamp 4 visa required

Clean Utilities Commissioning and Qualification Engineer - Dun Laoghaire, Dublin

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 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.

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.

Package

Contract role - Hourly rate €60 - €70 per hour

Minimum 12 month contract with the possibility of an extension. 

Onsite expectations: 5 days per week



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