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CQV Engineer

3 weeks ago

Dublin, Dublin City, Ireland hays-gcj-v4-pd-online Full time

Your new company

At Hays Specialist Recruitment we have a great opportunity for a CQV Engineer to join our Biopharmaceutical client in Dublin on an initial 16-month contract.
The ideal candidate should hold a minimum of a BS qualification (Degree) in a scientific, technical or engineering discipline along with a minimum of 5 years of experience within the pharmaceutical industry with familiarity with utility systems commissioning.

Your new role

Development and execution of CQV testing documentation for Equipment for the Sterile Drug product facility.Responsible for meeting key project deliverables for safety, CQV schedule and quality of project-related documentation/electronic records for equipment assigned.Responsible for ensuring GMP equipment is tested in compliance with good manufacturing practices, company policies and EU & FDA regulations.Responsible for ensuring that all non-GMP equipment is tested in compliance with project-related standards from a commissioning perspective.Deviation management associated with the assigned equipment and utilities.Risk Management – Identifies and categorises CQV risks according to their impact on commissioning and qualification. Generation of action plans to mitigate qualification risks.Execution of FAT testing and leveraging results into the overall qualification process for assigned equipment, facilities and utilities.Ensuring all assigned training is executed on time to meet site metrics.Qualifications:Demonstratable capacity to effectively execute the CQV testing approach assigned from initiation to completion.CQV project lifecycle experience from design through to C&Q and handover.Demonstrable experience of performing as part of a diverse team of CQV professionals/ contractors to deliver on tasks safely, with quality focus, on time and within budget.Experience in CQV of Drug Substance/Drug product sterile manufacturing equipment and Utilities with integrated automation platforms.Specific experience with the CQV preparation and execution for black utility systems, including compressed air plant steam, process waste, chilled water.Solid background of document preparation, execution, and task planning on CQV projects with a demonstrated record of on-time performance.Excellent communication skills and the ability to influence others.Demonstratable experience working in teams in a matrix environment to deliver CQV elements.