Cpl in partnership with our client Pfizer are seeking a CQV Engineer to join the team for an 11 month fixed term contract at their state of the art plant in Dublin Grange Castle. This role carries a hybrid working model.
Introduction:
The DS2 Project is Design, Construction and fit-out of a multiproduct large-scale Cell Culture facility, including 6x bioreactors (13,200L), associated scale-up trains, support equipment, and a single purification suite to double existing site capacity. Forecasted demand of licensed and pipeline products exceeds the available capacity within the Pfizer Global Supply (PGS) network, hence the requirement for this project.
Location: Grange Castle/A&E Firm (Jacobs, Dublin Office)
Project Background:
The project is currently in Detailed Design Engineering with Jacobs Engineering. Construction on site is significantly advanced (PM Group as Construction Managers). FAT have already been completed for some equipment. The project has targeted for CQV completion in 2026.
Purpose of the Role:
Your role will be the development of the CQV package of documentation and later the installation/ commissioning and qualification of process equipment and utilities that are within the DS2 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.
Reporting to the CQV Lead role is responsible to:
1. Participate in design document reviews and ensure that quality aspects are included in design.
2. Attend FAT and execution of agreed testing protocols and sign off on permission to ship forms.
3. Generate CQV documents at project level and for specific equipment/systems. Liaising with Quality, Engineering and CQV to align on Critical parameters and document content.
4. Track and confirm closure of actions items identified through FAT, HAZOP, Design Qualification and other reviews.
5. 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.
6. Participate in construction system completion walkdowns.
7. Perform shakedown and commissioning and qualification of systems.
Education/Experience:
To be successful in this role you will require:
1. B.Sc/B.Eng. degree in engineering discipline, with particular emphasis mechanical or process engineering.
2. Minimum of 4 years’ experience from biotechnology or pharmaceutical GMP manufacturing/CQV environment.
3. Demonstrated ability to work on own initiative and proactively respond to business needs.
4. Excellent interpersonal and communication skills.
5. Familiar with Delta-V & Navis Works an advantage.
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