Junior CQV Engineer

3 weeks ago

Dublin, Dublin City, Ireland QCS Staffing 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. 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

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