CQ SME Senior Engineer

Job Description:

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
• Adherence to EU Annex 15
• Actively Support CQ Documentation (FRAs, DQs, Gap Assessment, Lonza 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
• Deviation/Incident Management & Change Control (Process)
• Punch List Management
• Vendor Management & Management of Third Party Support
• Reviewing CQ test plans and specifications prior to their approvals and post execution
• Management and Filing of CQV related documentation
• System and Area Handover

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.
• Developing positive working relationship with team members and USER groups
• Ensuring adherence to schedule, manhours and quality
• 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
• Risk Assessments, GAP Analysis, DQ Execution
• Review of Vendor Docs incl FAT and SAT, IQ and OQs
• Development of Lonza CTPs, IQ and OQ

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 LOTOTO 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
• Coordinate CQV execution activities in conjunction with Vendors and Lonza Automation Group
• 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)
• Ensuring compliance of the commissioning activities with qualification requirements where test results are subject to leveraging (FAT, VTOD, CTOD and SAT)
• Tracking of changes, punch items and deficiencies
• 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

Project Controls:

• Planning & Scheduling
• Support with 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 actualized and forecasting data for Doc Prep and Execution Phases
• Input to monthly project report including but not limited to:
• Progress Reporting & Progress measurement
• Scope changes
• Risks, Challenges and Mitigations

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.
• Positive Feedback from Customer (i.e. Quality, HSE, operations)
• Safety: No lost time accident and Focus on Start Up Safety
• 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
• Quality: Compliance with GDP, all deviations resolved to Client satisfaction and handover completed for all systems.
• Project Controls: Support with scheduling, punch item management, reporting and progress measurement

Required Skills:

SME

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