Junior CQV Engineer

2 weeks ago

Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full time
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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