This is a 12-month initial contract with a view to extension.
Owns projects, equipment, responsible for document drafting and protocol execution Overview: Clean Utilities Commissioning and Qualification (C&Q) engineer for various capital projects.
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 (URSs) 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.
Skills: Clean Utilities Equipment Qualification Documentation