CQV Engineer Utilities

2 weeks ago


Dublin, Dublin City, Ireland Cpl Full time

Company Profile:

Our client a leading multinational Biopharmaceutical organization based in Dublin are hiring for a CQV Engineer specialized in utilities systems support on an initial 12 month contract basis.

The company in question have a steady pipeline of products in development and are therefore expanding their operations in the area. It would be based on a highly modernized site with cutting edge equipment which has seen sizeable investment in recent times.

Core Responsibilities:

Development and execution of CQV testing documentation for Utilities 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 and utilities assigned.Responsible for ensuring Utilities are tested in compliance with good manufacturing practices, company policies and EU & FDA regulations.Responsible for ensuring that all non GMP equipment Utilities 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.Interfacing daily with key site stakeholders, vendors, and involved contractors.Conduct field inspections, FAT/SAT support, and walkdowns to verify system installation and operation.

Essential Requirements:

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.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 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.

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