Company Profile:
Our client a globally renowned biopharmaceutical company based in Dublin are hiring for a CQV Engineer specialized in clean utilities systems on an initial 12-month contract for an exciting project. This is an on-site role suited to those with a familiarity working sterile drug product filling line project.
Key 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, 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.
Essential Requirements:
- A minimum of a BS qualification (Degree) in a scientific, technical or engineering discipline
- 5 years of experience within the pharmaceutical industrial ideally with familiarity with Sterile Drug Product filling line experience.
- 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.
- 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 platform (e.g. ValGenesis, Kneat).
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