Junior CQV Engineer - Ireland, Dublin - 12 Month Contract
One of the top 10 best companies to work in Ireland is looking for aJunior 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 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.
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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