CQV Engineer

CQV Engineer - Pharmaceuticals - Contract - Dublin, Ireland

Do you want to work with an exciting company who are an established market leader within their niche field? We have a fantastic opportunity for a CQV Engineer to work on an exciting capex project in Ireland.

Your role will be to support the project between the A&E firm and onsite client project team for the development of the C&Q package of documentation and later the installation/ commissioning and qualification of filling line equipment that are within the project scope. The job holder will provide technical expertise to ensure that systems, equipment, and processes are designed, installed, commissioned, and qualified to the agreed specifications. 

CQV Engineer Responsibilities:

• Participate in design document reviews and ensure that quality aspects are included in design.
• Attend FAT and execution of agreed testing protocols and sign off on permission to ship forms.
• Generate CQV documents at project level and for specific filling line (syringe / vial / lyophiliser) equipment/systems. Liaising with Quality, Engineering and CQV to align on Critical parameters and document content.
• Work with the automation teams, ensure that process descriptions are provided, and Functional Specs are reviewed and approved to ensure that the automation element of the project meets schedule.
• Partake in Hazops and other required process safety reviews.
• Track and confirm closure of actions items identified through FAT, HAZOP, Design Qualification and other reviews.
• Maintain a strong interface with the Automation and Engineering teams to ensure that the information flow meets the needs of the Automation and Engineering teams, resolving issues as they arise.
• Participate in construction system completion walkdowns.
• Perform shakedown and commissioning and qualification of systems.

About you

• B.Sc/B.Eng. degree in engineering discipline, with particular emphasis mechanical or process engineering.
• Minimum of 8 years’ experience from fill finish in a pharmaceutical GMP manufacturing/CQV environment.
• Demonstrated ability to work on own initiative and proactively respond to business needs.
• Excellent interpersonal and communication skills.
• Familiar with Val Genesis an advantage

If this sounds like the position for you then please apply today!

The candidate must have the rights to work in the location stated in the job advert.

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