Job Details:
CPL is seeking a highly skilled CQV Engineer to join our client, a leading multinational Biopharmaceutical organization based in Dublin. This is an initial 12-month contract position.
Responsibilities:
* Develop and execute CQV testing documentation for Utilities for the Sterile Drug product facility.
* Ensure Utilities are tested in compliance with good manufacturing practices, company policies, and EU & FDA regulations.
* Deviation management associated with assigned equipment and utilities.
* Risk Management – Identify and categorize CQV risks according to impact on commissioning and qualification.
* Execute FAT testing and leverage results into overall qualification process for assigned equipment, facilities, and utilities.
* Interfacing daily with key site stakeholders, vendors, and involved contractors.
* Conduct field inspections, FAT/SAT support, and walkdowns to verify system installation and operation.
Requirements:
* Minimum of BS qualification (Degree) in 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.
* Experience in CQV of Drug Substance/Drug product sterile manufacturing equipment and Utilities with integrated automation platforms.
* Solid background of document preparation, execution, and task planning on CQV projects.
* Excellent communication skills and ability to influence others.
This role requires excellent communication skills, attention to detail, and the ability to work effectively in a matrix environment.