Commissioning and Qualification Lead
1 month ago
Job Description:
- Lead a team preparing and executing HVAC commissioning documents, ensuring achievement of the project schedule, track and report progress to the C&Q Manager.
- Provide a strong working technical knowledge of HVAC systems regarding the development of protocols, their execution, and close out.
- Provide technical oversight to a HVAC commissioning team to assure technical work quality, consistency, and alignment with the C&Q programme.
- Work closely with the C&Q Program Lead to ensure there is a key focus on traceability to User Requirements throughout both Commissioning and Qualification.
- Direct responsibility for development and execution of HVAC and clean room Qualification documents. In this role, the interface with the commissioning team will be to ensure that the systems are immediately ready for Qualification following commissioning with only repeat testing (or leveraging) of Quality Critical room conditions for Grade D clean rooms. The successful candidate is directly responsible for Qualification execution (or leveraging).
- Coordinate with the Engineering Compliance team, the QA team and other stakeholders in assuring all decisions on the document preparation for HVAC systems are aligned and agreed.
- Work collaboratively with the other project disciplines (e.g. automation, construction, engineering, end user) to support integration of activities.
- Train HVAC personnel on the C&Q programme and it’s implementation in execution.
- Work directly with the commissioning delivery partner and the HVAC balancing contractor to plan, schedule and implement balancing of HVAC. Hands on leadership of balancing execution is a key requirement.
- Execute Qualification of Process systems as needed, particularly in Installation Qualification.
Requirements :
7 years minimum C&Q doc prep and execution experience in the Pharmaceutical sector with a minimum of 3 in a leadership role.
• Demonstrated HVAC and clean room Qualification ownership.
• Demonstrated leadership and people management skills.
• Knowledge of GMP’S, regulatory requirements, equipment commissioning and qualification.
• Good communication skills
• Ability to work well in a team environment.
• Able to manage multiple parties and coordination.
• Proficient in the use of DeltaV.
• Proficient in the use of Kneat.
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