We are working on behalf of a leading global biologics company seeking a Commissioning and Qualification (C&Q) engineer for various capital projects. The correct candidate must be ensure the C&Q activities associated with various capital projects are completed safely, as per schedule and in compliance with GMP and Quality Requirements.
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).
Education / Experience:
* 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.
