Role: CQV EngineerScroll down to find the complete details of the job offer, including experience required and associated duties and tasks.
- Clean Utilities Location: Dublin Contract: 12-month contract Onsite role At Hays Specialist Recruitment we have a great opportunity for a CQV Engineer to join our Biopharmaceutical client in Dublin on an initial 12-month contract.Responsibilities
* 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 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.Required Competencies 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, as well as 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.Val Genesis, Kneat).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 industry, ideally with familiarity with Sterile Drug Product filling line experience.The role is a site role.Req
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xsokbrcHays Ireland is a trading division of Hays Specialist Recruitment (Ireland) Limited and acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers.