Job Summary

The scope of CQ activities relates to Fill Finish and Process Support Equipment, where schedule allows.

The CQ FF SME is responsible for coordinating CQ related activities including supporting Documentation Preparation, FAT, Installation, Hook Up, MC Oversight, active CQ Execution involving Safe / LOTO Team, Various Vendors, Calibration Group, Automation, CQV Team and USER - Ops and QA Team.

Main responsibilities

General Management and Coordination

• Meeting and delivering key project milestones
• Implementation of CORP-35 and supporting guidelines
• Actively Support CQ Documentation (FRAs, DQs, Gap Assessment, Commissioning, IQs and OQs)
• CQ Execution Readiness (Permits, Availability of Materials and Consumables, Tooling, Calibrations, Utilities, Ops support, Automation support and CQV support)
• Hands On CQ Execution (Vendor Oversight, Execution of Commissioning Protocols, IQ and OQ Test Plans)
• Participate in MC, P+ID Walk down and Punch item Categorisation
• Punch List Management

Main responsibilities and tasks relating to CQV documentation:

• Coordinating development and approvals with the Client, Construction QA lead, and with other disciplines including Vendors, Automation, E+I, and USER etc.
• Review and approval of VTOD and CTOD
• Generation (Kneat digital platform) & execution of commissioning & qualification protocols
• Actively support Doc Prep team within the Kneat Systems
• Review of Vendor Docs incl FAT and SAT, IQ and OQs

Execution Readiness:

• FAT support where requested
• Documented training on PSPs
• Monitoring and coordinate MC readiness
• CQV documentation readiness
• Monitoring and coordinate Automation readiness
• Monitor and coordinate SUT installation
• HSE Plans, System PSSRs and LOTOTO device readiness
• Vendor notification of SAT dates per CQ Schedule

CQV Execution:

• HSE management in conjunction with HSE Lead
• MC acceptance
• Execution of commissioning test protocols, IQ and OQ
• Vendor Management during SAT (Scheduling, Arrival On site, HSE Induction, SAT, IQ and OQ Oversight, Training, Handover)
• Reviewing first of type CQ test reports prior to their approvals
• Assisting system leads/engineers with system handover to production
• PQ and PPQ support where necessary

Key Performance Indicators

• Strong knowledge and experience of Process Commissioning and Qualification Fill Finish and Process Support Equipment
• Management: Compliance with a schedule at a system and area level with the planned resource levels.
• Equipment Functionality: Robust and Repeatable Commissioning with no spurious alarms in line with URS, Technical and Functional specs. Well-executed Kneat Test protocols with minimum rework, deviations and re-execution
• Project Controls: Support with scheduling, punch item management, reporting and progress measurement