HVAC Commissioning and Qualification Manager
2 months ago
Position Summary:
- Oversee a dedicated team responsible for the preparation and execution of HVAC commissioning documentation, ensuring adherence to project timelines while monitoring and reporting progress to the C&Q Manager.
- Utilize extensive technical expertise in HVAC systems to guide the development of protocols, their implementation, and subsequent closure.
- Provide technical leadership to the HVAC commissioning team, ensuring high-quality work, consistency, and alignment with the C&Q program.
- Collaborate closely with the C&Q Program Lead to maintain a strong focus on traceability to User Requirements throughout the Commissioning and Qualification processes.
- Hold direct accountability for the creation and execution of HVAC and clean room Qualification documents, ensuring systems are primed for Qualification post-commissioning, with only necessary repeat testing of Quality Critical room conditions for Grade D clean rooms.
- Coordinate with the Engineering Compliance team, QA team, and other stakeholders to ensure that all decisions regarding HVAC documentation are aligned and mutually agreed upon.
- Work in partnership with various project disciplines (e.g., automation, construction, engineering, end users) to facilitate the integration of activities.
- Educate HVAC personnel on the C&Q program and its practical application in execution.
- Collaborate directly with the commissioning delivery partner and HVAC balancing contractor to strategize, schedule, and implement HVAC balancing, with a strong emphasis on hands-on leadership during execution.
- Conduct Qualification of Process systems as required, particularly focusing on Installation Qualification.
Qualifications:
A minimum of 7 years of experience in C&Q document preparation and execution within the Pharmaceutical industry, including at least 3 years in a leadership capacity.
• Proven track record of ownership in HVAC and clean room Qualification.
• Strong leadership and personnel management capabilities.
• Comprehensive understanding of GMPs, regulatory standards, equipment commissioning, and qualification.
• Excellent communication skills.
• Ability to thrive in a collaborative team environment.
• Skilled in managing multiple stakeholders and coordinating efforts.
• Proficient in DeltaV software.
• Experienced in using Kneat software.
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