CQV Engineer

Team Horizon is seeking a CQV Engineer for a leading manufacturing company in Mayo.

The CQV Engineer collaborates closely with project teams, contributes to documentation, and actively participates in field execution. This role ensures systems are installed, commissioned, qualified, and validated in line with project requirements, regulatory guidelines, and industry standards.

Why you should apply:

• Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.


• You enjoy working on exciting projects and want to work with a global manufacturing site in Mayo.

What you will be doing:

• Client-side lead to work with equipment vendors to support the CQV lifecycle activities as part of a new facility start-up project.


• Responsible for developing and executing commissioning and qualification documentation for new systems and equipment.


• This will include supporting the complete CQV lifecycle; Writing URS documents, review / approval of Design Specifications, input into the control strategy, development and execution of the test matrix (leveraged) to support offsite / onsite execution (as per ASTM E2500).


• Participate in and support field execution of commissioning and qualification testing, ensuring accurate data collection, evaluation, and reporting.


• Experience of working with equipment vendors to develop and execute the CQV lifecycle.


• Assist in troubleshooting, resolution of issues, and investigation of deviations during system start-up and qualification.


• Collaborate with engineering, construction, operations, and quality teams to ensure seamless project execution.


• Ensure adherence to cGMP, FDA, EU, ISPE, and other regulatory standards relevant to system validation.


• Assist with project scheduling, coordination of vendors/contractors, and inventory of required materials/parts for CQV activities.


• Maintain robust, compliant, and traceable documentation of all CQV processes.


• Identify opportunities for improvement and contribute to best-practice CQV procedures.

What you need to apply:

• Bachelor’s Degree in engineering or scientific discipline preferred.


• Direct experience performing validation studies in cGMP biopharmaceutical or aseptic filling environment is required.


• Knowledge of aseptic processing and liquid filling operations preferred.


• Must be able to analyse data using basic statistical methods.


• 3 years of CQV experience in a regulated industry (pharmaceutical, biotechnology, medical device, etc.), covering multiple systems: process, utilities, and/or HVAC.


• Demonstrated experience with development and execution of CQV protocols and documentation (FAT/SAT, IQ, OQ, PQ).


• Willingness to travel and participate in on-site fieldwork as required.


• Solid understanding of process equipment, clean utilities, black utilities, and HVAC system operations.


• Strong analytical, documentation, and organizational skills.