Junior Cqv Engineer

5 days ago

Dublin, Ireland Quanta Consultancy Services Ltd Full time

Overview
Junior CQV Engineer - Ireland, Dublin - 12 Month Contract
One of the top 10 best companies to work in Ireland is looking for a Junior CQV Engineer 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
Responsibilities include:
Support the Sterile Drug Product Facility project as part of the CQV team.
Develop and execute commissioning and qualification plans for new and existing equipment and systems.
Perform equipment and system start-up activities, including functional testing and troubleshooting.
Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
Develop and execute validation protocols to support facility/utilities, equipment and computer systems validation.
Ensure that validation activities comply with regulatory requirements (e.g., FDA, EMA, ICH) and industry standards (e.g., GAMP 5).
Maintain validation documentation and ensure it is up-to-date and audit-ready.
Identify opportunities for process improvements and implement changes to enhance efficiency and compliance.
Qualifications
Key requirements include:
The candidate should hold a minimum of a BS qualification (Degree) in a scientific, technical, or engineering discipline.
Previous CQV experience is an advantage, previous GMP experience is essential.
The ideal candidate would have biopharmaceutical Process / Validation knowledge.
Exposure to cGMP in a fast-paced environment is required.
Previous experience in working in a drug product filling facility would be advantageous.
If this role is of interest, please apply now
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