Job description: Company: Profile:Our client a leading multinational Biopharmaceutical organization based in Dublin are hiring for a CQV Engineer specialized in component prep formulation 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. It would be based on a highly modernized site with cutting edge equipment which has seen sizeable investment in recent times.Core Requirements:
Lead prepare and execute the site commissioning and validation testing for equipment utilities at Drug Product Facility in alignment with site and global procedures.
Development and execution of CQV testing documentation for Equipment 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 assigned.
Responsible for ensuring GMP equipment are tested in compliance with good manufacturing practices, company policies and EU & FDA regulations.
Responsible for ensuring that all non GMP equipment, 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.
Requirements:
Minimum of a BS qualification in a scientific, technical or engineering discipline along with a minimum of 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 with integrated automation.
Specifically experience with CQ of Single Use Mixers & TCUs, Utility Panels & Filtration Systems (TFF), Autoclaves, Parts Washers and Powder Handling equipment such as Blenders and Jet Mills.
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.
#LI-PC2
Expected salary:
Location: Dublin
Job date: Fri, 16 May 2025 04:05:16 GMT
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