PE Global is currently recruiting for a CQV Engineer on behalf of a leading biotech company based in Dublin South.
This is an initial 12-month contract role.
Overview
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.
Responsibilities
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).
Education / 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
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***
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