CQ Fill Finish Engineer

vor 3 Wochen

Basel, Basel-Stadt, Schweiz Project Delivery Partners Vollzeit
CQ Fill Finish Engineer

At Project Delivery Partners, we are seeking a highly skilled CQ Fill Finish Engineer to join our team.

  • As a CQ Fill Finish Engineer, you will be 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 Client USER - Ops and QA Team.
  • You will ensure adherence to the Baseline Schedule, Functional, Technical, and GDP Compliance and adherence to Start Up safety procedures in line with best practices and Project expectations.
  • You will be responsible for General Management and Coordination in conjunction with Client and PDP Team, including Meeting and delivering key project milestones, Implementation of CORP-35 and supporting guidelines, Adherence to EU Annex 15, and Actively Support CQ Documentation (FRAs, DQs, Gap Assessment, Client Commissioning, IQs, and OQs).
  • You will also be responsible for 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), and Participate in MC, P+ID Walk down, and Punch item Categorisation.
  • You will also be responsible for 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, and Management and Filing of CQV related documentation.
  • You will also be responsible for System and Area Handover, Coordinating development and approvals with the Client, Construction QA lead, and with other disciplines including Vendors, Automation, E+I, and USER etc.
  • You will also be responsible for Developing positive working relationships with team members and USER groups, Ensuring adherence to schedule, man-hours, and quality, Review and approval of VTOD and CTOD, Generation (Kneat digital platform) & execution of commissioning & qualification protocols, and Actively support Doc Prep team within the Kneat Systems.
  • You will also be responsible for Risk Assessments, GAP Analysis, DQ Execution, Review of Vendor Docs incl FAT and SAT, IQ and OQs, Development of Client CTPs, IQ and OQ, Execution Readiness (FAT support where requested, Documented training on PSPs, CQ Team development and resource 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, and Vendor notification of SAT dates per CQ Schedule).
  • You will also be responsible for Materials, consumables, spares, first fill available in stores, Ensuring the fulfilment of the general pre-requisites, needed to start with 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 Client 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, and PQ and PPQ support where necessary.
  • You will also be responsible for 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, and 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, and 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).

Key Requirements:

  • 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.

What We Offer:

  • A competitive salary and benefits package.
  • The opportunity to work with a leading company in the industry.
  • A dynamic and supportive team environment.
  • Professional development and growth opportunities.

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