Job Description
We are seeking a CQV Engineer to join our team in Dublin for an initial 14-month contract. The successful candidate will work closely with the CQV Lead to prepare and execute site commissioning and validation testing for equipment utilities at the Drug Product Facility.
Key Responsibilities:
* Develop and execute CQV testing documentation for Equipment at the Sterile Drug product facility.
* Meet key project deliverables for safety, CQV schedule, and quality of project-related documentation/electronic records for assigned equipment.
* Ensure GMP equipment is tested in compliance with good manufacturing practices, company policies, and EU & FDA regulations.
* Ensure all non-GMP equipment is tested in compliance with project-related standards from a commissioning perspective.
CQV Project Lifecycle Experience:
* Design through to C&Q and handover experience.
* Perform as part of a diverse team of CQV professionals/contractors to deliver on tasks safely, with a quality focus, on time, and within budget.
* Experience in CQV of Drug Substance/Drug product sterile manufacturing equipment with integrated automation.
Requirements:
* Demonstrable capacity to effectively execute the CQV testing approach assigned from initiation to completion.