CQV Engineering Professional

7 days ago

Dublin, Dublin City, Ireland beBeecqv Full time €60,000 - €90,000

**Job Title:** Junior CQV Engineer

We are currently seeking a skilled CQV Engineer to join our team in Dublin, Ireland. This is an exciting opportunity to work on a large-scale new facility project.

As a CQV Engineer, you will be responsible for supporting the Sterile Drug Product Facility project as part of the CQV team. Your key responsibilities will include:

  • Developing and executing commissioning and qualification plans for new and existing equipment and systems.
  • Performing equipment and system start-up activities, including functional testing and troubleshooting.
  • Developing and executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
  • Developing and executing validation protocols to support facility/utilities, equipment and computer systems validation.

You will also ensure that validation activities comply with regulatory requirements (e.g., FDA, EMA, ICH) and industry standards (e.g., GAMP 5). Additionally, you will maintain validation documentation and ensure it is up-to-date and audit-ready.

To be successful in this role, you should have 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.

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