Job Description
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 (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.