Pharmaceutical Commissioning Expert
4 days ago
We are looking for an experienced CQV Engineer to join our team. As a CQV Engineer, you will be responsible for ensuring the smooth operation of our clean utility systems. This is an excellent opportunity to join a world-class manufacturing operation and contribute to the development of innovative solutions that improve health outcomes and dramatically improve people's lives.
Your Key Responsibilities
- Commissioning & Qualification of Clean Utility Systems and execution of qualification documentation.
- Generation of all C&Q test documents (C&Q Plan/Set to Works/FAT/SAT/IV/FT/C&Q Summary Report).
- Provide technical assistance during investigations and system design.
- Coordinates and Supervises all C&Q activities on their systems.
- Ensures the C&Q schedule is maintained.
- Manages Daily C&Q coordination meetings.
- Responsible for Tracking and Reporting of C&Q status and risks/issues.
- Ensures Startup of equipment/utilities is completed in a safe and coordinated manner.
- Assist in the development of User Requirement Specifications (URS's) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).
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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