Career Opportunity: CQV Engineer for Sterile Drug Product Facility
We are seeking an experienced CQV Engineer to join our team in a Sterile Drug Product facility. This is a highly specialized role that requires expertise in commissioning and qualification of equipment, utilities, and facilities.
Main Responsibilities:
* Lead the preparation and execution of site commissioning and validation testing for equipment utilities.
* Develop and execute CQV testing documentation for Equipment for the Sterile Drug product facility.
* Ensure compliance with good manufacturing practices, company policies, and EU & FDA regulations.
* Manage deviations associated with assigned equipment and utilities.
* Identify and categorize CQV risks according to impact on commissioning and qualification.
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.
* 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.
About Us:
We offer a dynamic and challenging work environment that allows our employees to grow professionally and personally. We are committed to delivering high-quality products that meet the needs of our customers.