Purpose
Owns projects, equipment, responsible for document drafting and protocol execution
Clean Utilities/ Facilities / Equipment Commissioning and Qualification (C&Q) engineer for a capital project. Ensure the C&Q activities associated with the capital project are completed safely, as per schedule and in compliance with GMP and Quality
Requirements.
Responsibilities
* Commissioning & Qualification of Clean Utility Systems / Facility and Process equipment.
* 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).
Qualifications
* 3+ 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.