Quality Assurance Engineer
4 days ago
Company Overview
Team Horizon is a leading pharmaceutical company in South Dublin, renowned for its world-class manufacturing operation and commitment to delivering high-quality medicines to patients worldwide.
We pride ourselves on a strong culture of continuous improvement and innovation, striving for solutions that improve health outcomes and make a significant impact on people's lives.
Job Description
We are seeking an experienced CQV Engineer to join our team. As a key member of our commissioning and qualification team, you will be responsible for the successful delivery of clean utility systems and execution of qualification documentation.
Your primary focus will be on generating all C&Q test documents, providing technical assistance during investigations and system design, and ensuring the C&Q schedule is maintained.
You will also be responsible for coordinating and supervising all C&Q activities on our systems, tracking and reporting of C&Q status and risks/issues, and ensuring startup of equipment/utilities is completed in a safe and coordinated manner.
Required Skills and Qualifications
To be successful in this role, you will need:
- 6+ years experience in Engineering or Commissioning and Qualification Management;
- Technical qualification at third level or equivalent in Engineering;
- Extensive knowledge and demonstrated experience managing Commissioning and Qualification for Pharmaceutical / Biotechnology projects preferred;
- Knowledge of safety, GMP and environmental regulatory requirements;
- Demonstrated strong Communication and Leadership skills;
- Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes;
- Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry;
- Familiarity with paperless validation systems.
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