Direct message the job poster from PE Global
Contracts Consultant chloe.slingsby@peglobal.net 0860200448
PE Global are recruiting for a CQV Engineer for our biopharmaceutical client based in Dun Laoghaire, Dublin.
This is an initial 12-month contract role, with the possibility of extension. Fully onsite.
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.
Job Responsibilities
* 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.
* Ensure the C&Q activities associated with the capital project are completed safely, as per schedule and in compliance with GMP and Quality Requirements.
* 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).
Educations & 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
* Familiarity in sterile fill/finish processes is a must.
* Full C&Q lifecycle experience is preferred.
* Daily collaboration with Project Engineers, Validation, QA, and Operations is essential.
* Routine meetings for coordination and issue resolution are part of the role.
* Flexibility is key as candidates will need to manage multiple documents and systems simultaneously, reflecting the dynamic nature of the work environment.
* 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, or alternatively send an up-to-date CV chloe.slingsby@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****
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Contract
Job function
* Job function
Manufacturing and Engineering
* Industries
Pharmaceutical Manufacturing
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