CQV Engineer

Submit Your Resume CV Job Search Graduate Opportunities Submit Your Resume CV Job Search Graduate Opportunities CQV Engineer Location: Dublin 15 Employment Type: Full-Time Date Posted: 11/Aug/2026 Apply for this job CQV Engineer Formulation & Component Prep

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 are tested in compliance with good manufacturing practices, company policies and EU & FDA regulations. Responsible for ensuring that all non GMP equipment, are tested in compliance with project related standards from a commissioning perspective. Deviation management associated with the assigned equipment and utilities. Risk Management – Identifies and categorizes CQV risks according to impact on commissioning and qualification. Generation of action plans to mitigate qualification risks. Execution of FAT testing and leveraging results into overall qualification process for assigned equipment, facilities and utilities. Ensuring all assigned training is executed on time to meet site metrics. Required Competencies Demonstratable capacity to effectively execute the CQV testing approach for assigned from initiation to completion. CQV project lifecycle experience from design through to C&Q and handover. Demonstrable experience of performing as part of 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 with integrated automation. Specifically experience with CQ of Single Use Mixers & TCUs, Utility Panels & Filtration Systems (TFF), Autoclaves, Parts Washers and Powder Handling equipment such as Blenders and Jet Mills. 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. Required Qualification(s) and Desired Experience 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 industrial ideally with familiarity with Sterile Drug Product filling line experience.

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