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. This exciting project offers the opportunity to learn new technology and develop current skills within a fast-paced €1 billion project, in a large-scale environment with cutting edge technology.
Responsibilities
* 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 / Requirements
* 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.
Seniority level
* Entry level
Employment type
* Contract
Job function
* Engineering and Information Technology
Location: Dublin, County Dublin, Ireland
#J-18808-Ljbffr