Senior Cqv Engineer

3 days ago

County Dublin, Ireland Pe Global Full time
: PE Global is currently recruiting for a Senior CQV Engineer on behalf of a leading biotech company based in Dublin South.
This is an initial 12-month contract role.
Overview: 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 (URSs) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).
Education / Experience: 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.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Kellie on or alternatively send an up to date CV to ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland*** Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application.
You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you.
You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy.
Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert.
Skills: commissioning qualification validation clean utilities

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