CQV Engineering Specialist

3 days ago

Dublin, Dublin City, Ireland beBeeCQVEngineer Full time €60,000 - €90,000
Job Title: CQV Engineering Specialist

We are seeking an accomplished CQV Engineer to join our team, focusing on equipment, utilities, and computer systems validation.


About the Role:
  • This position involves supporting the Sterile Drug Product Facility project as part of the CQV team.
  • The successful candidate will develop and execute commissioning and qualification plans for new and existing equipment and systems.
  • The primary responsibilities include performing equipment and system start-up activities, including functional testing and troubleshooting.
  • Key deliverables include developing and executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
  • The engineer must ensure that validation activities comply with regulatory requirements (e.g., FDA, EMA, ICH) and industry standards (e.g., GAMP 5).

Requirements & Expectations:
  • A bachelor's degree in a scientific, technical, or engineering discipline is mandatory.
  • Prior experience in CQV is advantageous, while prior GMP experience is essential.
  • Familiarity with cGMP practices in a fast-paced environment is required.

Maintaining strong communication skills is crucial for effective communication of validation plans, progress, and results to stakeholders. Collaboration with cross-functional teams, including Quality Assurance, Manufacturing, Engineering, MS&T Process, and Regulatory Affairs, is also essential.

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