Job Summary - Raleigh
2 days ago
Job description
Job Summary
The HVAC CQV Lead is responsible for supporting the planning, preparation and leading a field execution team of C&Q specialists with the CQ activities related to HVAC for meeting the agreed objectives regarding budget, schedule and C&Q methodology according to the Project Commissioning and Qualification Plan, and ensuring URS, GMP, Safety and environmental objectives are met
Main responsibilities
Main responsibilities and tasks of the incumbent includes but are not limited to:
- Leading and coordinating a commissioning team that consists of commissioning and qualification leads/specialists, operations personnel, system leads/engineers, document controllers and external vendors and contractors
- Planning and scheduling the commissioning activities according to the Project Commissioning and Qualification Plan, project schedule and its associated documents, including:
- Meeting and delivering Key Project Milestones
- Developing positive working relationship foster collaboration with Quality
- Defining workflows and approval cycles for commissioning test plans and specifications
- Updating the Project Commissioning and Qualification Plan and its related documents as well as other project specific procedures with commissioning relevance.
- Updating the commissioning schedule by including the activities relevant for the preparation of commissioning test plans and test specifications
- Guiding the preparations of commission test plans and specifications to ensure unique structures and formats and testing standards
- Reviewing commissioning test plans and specifications prior to their approvals
- Progress tracking of the preparation of commissioning test plans and specifications
- Coordinating the planning and scheduling of commissioning activities with the construction project manager, construction C&Q, and with other disciplines (Construction, Automation, Electrical, Instrumentation, User operation and Site engineering, etc.)
- Guiding and controlling of the CQ execution, including:
- Ensuring the fulfilment of the general pre-requisites, needed to start with commissioning execution to determine when systems are ready for beneficial use (Construction Completion, availability of tools, utilities, spares, documents, etc.)
- Ensuring sufficient safety training for all involved persons
- Coordinating the interfaces of the commissioning execution (Construction Management Contractor, Building/ Building Services, Qualification, Automation, Instrumentation, Electrical, etc.)
- Performing daily coordination meetings to fine-tune the commissioning execution with all involved parties
- Tracking and reporting of commissioning progress
- Tracking of deficiencies, including planning and executing the remediation actions
- Ensuring compliance of the commissioning activities with qualification requirements where test results are subject of leveraging
- Reviewing commissioning test reports prior to their approvals
- Assisting system leads/engineers with system handover to production
Key Performance Indicators
Ideal Background
- Education (minimum/desirable): Minimum BS or equivalent in Engineering or Science - preferably in Chemical, Mechanical or Pharmaceutical Engineering.
- Experience in Utility & HVAC Commissioning and Qualification.
- Languages: English - fluent in speaking and writing.
- Experience: Minimum 10-12 yrs.
- Broad knowledge of engineering disciplines, commissioning, compliance, qualification and quality aspects of biopharma or pharmaceutical manufacturing.
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