• Development and execution of CQV testing documentation for Clean 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, utilities assigned.
• Responsible for ensuring GMP equipment and Clean Utilities are tested in compliance with good manufacturing practices, company policies and EU & FDA regulations.
• Responsible for ensuring that all equipment and 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 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.

• 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.
• Specifically, experience with CQ of High Purity Water systems, Purified Water & WFI Generation and Distribution systems. And Clean Steam and High Purity Gas Systems
• 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.
• Previous experience with electronic validation platforms (e.g. ValGenesis, Kneat).

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