Clean Utility Systems Expert
3 days ago
What You Will Be Doing
In this role, you will be responsible for the following:
- 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 our 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).
Requirements
- 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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