Cqv Manager

Job Summary
The CQV Manager is responsible for planning, preparation, coordination and leading a CQV team from documentation preparation thought FAT, CM oversight, integrated CQ execution, PQ/PPQ support and successful handover to the Client USER team. The scope of CQV activities relates to Building Infrastructure, Utility, HVAC/Areas, Automation and Process Equipment. The CQV Manager will lead and coordinate a CQV team that consists of CQV leads/specialists, engineers, operations personnel, engineering and external vendors, contractors, sub-contractors including the automation integrator and CSV service provider. Aside to delivering in line with the Client QPP requirements, the CQV Manager will ensure that overall Budget, Baseline Schedule, Compliance, Quality and HSE objectives are achieved in line with Project expectations. The CQV Manager will for part of the Client leadership team attending core team meeting, providing guidance on CQ matters and post OQ support as required. Main responsibilities
Development of an overall CQV documentation plan in conjunction with project scheduler
Org chart development and resourcing
Lead various weekly multidisciplinary CQV, Eng, CM and USER coordination meetings
Defining workflows and approval cycles for CQV test plans and specifications
Coordinating development and approvals with the Client leads, Construction QA lead, and with other disciplines including Vendors, Automation, E+I, and USER etc.
Meeting and delivering key project milestones
Developing positive working relationship with team members and USER groups
Developing CQV related Project Specific Procedures including workflows in conjunction with the CQV team including but not limited to:
Documentation Management
HSE and Safe Start Up including PTW and LOTO
CQV Doc Preparation
CQV Execution Readiness
CQV Execution
MC, P+ID Walkdown and Punch item Categorisation
Deviation Management & Change Control (Process and Automation)
Punch List Management
Vendor Management
System and Area Handover
Reviewing CQV test plans and specifications prior to their approvals
Development and maintenance of training material, matrix and files for all those involved in CQV activities (Integrator, CSV provider, Vendors, Client USERs)
Management and Filing of CQV related documentation
Management and Coordination of CQ execution activities, including:
**Execution Readiness**:
FAT support where requested
Documented training on PSPs
CQ Team development and resource and allocation
Monitoring and coordinate MC readiness
CQV documentation readiness
Monitoring and coordinate Automation readiness
Monitor and coordinate SUT installation
Appointment of Sub Contracts
Calibration readiness including test equipment and resourcing
HSE Plans, System PSSRs and LOTO device readiness
Vendor notification of SAT dates per CQ Schedule
Materials, consumables, spares, first fill available in stores
Ensuring the fulfilment of the general pre-requisites, needed to start with CQV execution

**CQV Execution**:
Ensure daily multidisciplinary CQV, Eng, CM and USER coordination meetings are established
HSE management in conjunction with HSE Lead
MC acceptance
Manage CQV execution activities in conjunction with area CQV Leads
Tracking of changes, punch items and deficiencies
Reviewing first of type CQV test reports prior to their approvals
Assisting system leads/engineers with system handover to production
PQ and PPQ support where necessary Project Controls

**Main responsibilities and tasks include but not limited to**:
Planning & Scheduling
Development of an overall System based baseline CQV Schedule in conjunction with Engineering, CM and USER Group involving;
System Definition
System Classification
MC alignment with Construction
Handover alignment with USER
Fortnightly updates to CQ schedule including actualised and forecasting data for Doc pre and Execution Phases
Liaise with PMO and USER with inputs to PQ and PPQ schedule

Progress Reporting
Development of a monthly project report including but not limited to:
Contracts
Develop scope of work(s) for CQV related vendors and contractors
Working closely with procurement in relation to;
Bid analysis
Recommendations and Award
Payment schedule
Approval of invoices based on progress and or time sheets
Progress measurement
Invoice approval and stage payment
Cost
Manage overall cost on behalf of PDP/Client for CQV activates (Directs and Indirects)
Scope including schedule delay management and related change control
Man-hour and cost management
Sub contracts cost management Ideal Background
Experience in Process Commissioning and Qualification.

**Languages**: English - fluent in speaking and writing.

**Experience**: Minimum 10 yrs.
Broad knowledge of engineering disciplines, commissioning, compliance, qualification and quality aspects of biopharma or pharmaceutical manufacturing.