We are seeking a skilled C&Q Engineer to join our team in Dublin. The ideal candidate should have a strong background in CQV project lifecycle experience from design through to C&Q and handover.
Job Description
As a C&Q Engineer, you will be responsible for developing and executing CQV testing documentation for filling line systems, including Syringe and Vial line/isolators, Lyos, and associated equipment for the Sterile Drug product facility.
* Develop comprehensive CQV testing documentation for filling line systems.
* Execute CQV testing on filling line systems, ensuring compliance with good manufacturing practices, company policies, and EU & FDA regulations.
Key Responsibilities:
* Meet key project deliverables for safety, CQV schedule, and quality of project-related documentation/electronic records for equipment and utilities assigned.
* Ensure GMP equipment are tested in compliance with good manufacturing practices, company policies, and EU & FDA regulations.
* Ensure that all equipment is tested in compliance with project-related standards from a commissioning perspective.
* Manage deviations associated with the assigned equipment and utilities.
* Risk Management - Identify and categorize CQV risks according to impact on commissioning and qualification.
* Generate action plans to mitigate qualification risks.
About You
The ideal candidate should have a minimum of 5 years of experience within the pharmaceutical industry, ideally with familiarity with Sterile Drug Product filling line experience.