CQV Engineer – Utilities & Equipment
- Ireland, Dublin
- Contract
- Life Sciences
One of the top 10 best companies to work in Ireland is looking for a CQV Engineer – Utilities & Equipment for their large-scale new facility in Dublin. Is this you?
An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.
Responsibilities include:
- Deliver end-to-end CQV lifecycle documentation: URS, DQs, FAT/SAT, IQ, OQ, and support for PQ where applicable.
- Perform equipment and system commissioning, including verification of installation, utilities integration, control functionality, and safety systems.
- Conduct impact assessments, risk assessments (e.g. ASTM E2500), and define appropriate qualification strategies.
- Liaise with vendors, automation, engineering, and quality functions to coordinate execution and resolve issues.
- Support and lead the resolution of deviations, non-conformances, and change controls related to CQV scope.
- Maintain up-to-date and compliant documentation in line with GMP and data integrity requirements.
- Provide progress updates and contribute to system readiness reviews and handover milestones.
- Bachelor’s degree in Engineering, Life Sciences, or related technical field.
- Requires extensive CQV experience in a GMP-regulated drug substance or biologics manufacturing environment.
- Demonstrated hands-on experience with commissioning and qualification of: Large-scale bioprocess equipment, Utility systems (WFI, HVAC, compressed gases, clean steam), Automation-integrated equipment (DeltaV)
- Deep understanding of CQV best practices, ISPE Baseline Guides, GAMP 5, and ASTM E2500.
- Experience working on capital projects, preferably from construction to handover.
- Ability to work independently on protocol development, execution, and resolution management.
#LI-JS4
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
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