We are seeking a Clean Utilities Commissioning and Qualification (C&Q) Engineer to oversee a range of capital projects, ensuring that all activities are completed in compliance with GMP (Good Manufacturing Practices) and quality standards. This role involves the coordination and management of C&Q processes, from equipment commissioning to protocol execution, with a focus on safety, efficiency, and meeting project timelines.
Responsibilities:
- Lead the commissioning and qualification of Clean Utility Systems, ensuring all necessary documentation is executed.
- Prepare and manage all C&Q test documents, including C&Q Plans, FAT, SAT, IV, FT, and Summary Reports.
- Provide technical support during investigations and system design processes.
- Oversee and supervise all C&Q activities within your scope.
- Maintain the C&Q project schedule, ensuring timelines are met.
- Facilitate daily C&Q coordination meetings and manage progress.
- Track and report on C&Q status, risks, and issues, ensuring transparent communication.
- Ensure that all equipment and utilities startup activities are conducted safely and in an organized manner.
- Contribute to the creation of User Requirement Specifications (URS) and perform Quality Risk Assessments for Equipment and Automated Systems (QRAES).
Qualifications:
- A minimum of 6 years' experience in Engineering or Commissioning and Qualification Management.
- A technical qualification at the third level or equivalent in Engineering.
- Proven expertise in managing Commissioning and Qualification for pharmaceutical or biotechnology-related projects.
- In-depth knowledge of safety, GMP, and environmental regulatory requirements.
- Excellent communication and leadership skills.
- Ability to collaborate effectively with senior stakeholders to achieve project goals.
- Strong understanding of risk-based commissioning and qualification approaches in the biotechnology sector.
- Familiarity with paperless validation systems is a plus.
