Description:
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).
Qualifications & 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.