CQV Engineer
- Dublin
- Contract
- Commissioning, Qualification and Validation
This vacancy has now expired
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.
- 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.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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We have worked together with Quanta for seven years now and have always received a professional service. Quanta’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 Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
I have always received a highly professional & personable service from the team at Quanta. 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
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Caroline
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