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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