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CQV Engineer

  1. Ireland, Dublin
Dublin
  1. Contract
Competitive
  1. CAPEX Projects
36776
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CQV Engineer – Dublin – Pharmaceuticals

Our global client within the Biologics sector, is revolutionising the development and manufacturing of specialised medicines. Their state-of-the-art GMP facility, located away from their process development headquarters, ensures that every project is built upon sound science and innovation.

As they continue to expand, we are looking for passionate and talented individuals to join their dynamic, team-driven environment. They offer a unique opportunity to make a real difference in people's lives.

This specialist global biologics organisation are looking for a CQV Engineer to join their team.

Key Responsibilities:
  • Develop and execute commissioning, qualification, and validation activities for equipment, utilities, and systems.
  • Develop and implement CQV protocols (IQ, OQ, PQ, etc) and reports to ensure compliance with regulatory requirements.
  • Organise and work with vendors supporting CQV activities onsite.
  • Manage the workflows of key CQV activities and documentation to progress to system release and life cycle management such as requalification.
  • Troubleshoot and resolve technical issues related to CQV, including punch list item remediation, test exceptions, and deviations.
  • Maintain thorough and accurate documentation, ensuring data integrity and compliance with audit expections.
Qualifications & Requirements:
  • Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical, or related field) or equivalent experience.
  • Experience in CQV within the pharmaceutical, biotechnology, or life sciences industry.
  • Strong knowledge of GMP, EU regulations and industry validation guidelines.
  • Experience with CQV of biotech/pharmaceutical equipment, cleanrooms, utilities (HVAC, clean utilities).
  • Familiarity with risk-based approaches (ICH Q9, ASTM E2500) for validation.
  • Strong problem-solving and analytical skills.
 

If this role is of interest, please apply now.

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