CQ Execution Lead

vor 1 Woche

Bern, Bern, Schweiz Project Delivery Partners Vollzeit

Job Summary

The CQ Execution Lead is responsible for supporting the planning, execution and supervision of the entire Project Commissioning and Qualification field activities. To support meeting the agreed objectives regarding schedule and functionality according to URS, GMP, Safety and environmental objectives.

Main responsibilities

Main responsibilities and tasks of the incumbent includes but are not limited to:

  • Reporting to the PDP CQV Manager.
  • Attend coordination execution meetings, providing an update on issues, risks and showstoppers
  • Support SHE matters in:
    • Implementation of client SHE Plan & PTW procedures
    • Awareness training & implementation of LOTO and Safe Work Method Statements/Risk Assessments
    • Housekeeping
    • Audits with support from SHE manager
  • Support overall field coordination of Commissioning & Qualification activities
    • With CQV Manager Schedule, Priorities and Execution Matters
    • With CQ Verification Lead CTS readiness
    • With Project Quality - Quality Matters
    • With Automation Field Automation issues / readiness
    • With construction for no impact systems
    • Support look ahead schedule
    • Support measurement of Actual progress
    • Scheduling forecasting
  • Support coordinating the commissioning field team including commissioning and qualification engineers, AEI experts, user and site engineers, document controllers and external vendors and contractor
  • Support troubleshooting and resolution of Process related issues in a timely manner with CQ area leads.
  • Support the investigation, implementation & closure of deficiencies and deviations
  • Support schedule remediation activities
  • Reviewing the commissioning test reports and ensuring their completeness post execution
  • Confirming the overall completion of the commissioning execution
  • Supporting a team of CQ specialists, operators and technicians in the following tasks for each area:
    • FAT/ sFAT attendance and execution
    • Support on-site construction activities
    • Walk down of mechanically complete systems
    • Review of turnover binders from the various relevant contractors/suppliers.
    • Commissioning / functional testing of systems including Troubleshooting
    • Supporting IQ/OQ and PQ execution
  • Compliance with overall & CQ schedule including
    • Completion of tasks vs. schedule with daily meetings with team / resources to emphasise and communicate schedule targets, resolve issues, track progress and prioritise next actions.
    • Reporting progress for their area
  • Reporting stewardship including:
    • Helping team troubleshoot and resolve all issues.
    • Managing technical discussion on all deviations, changes, design issues and test failures.
    • Elevating to management any issues that cannot be resolved between the execution team and SMEs.
  • Quality Champion for their specific area including:
    • Ensuring documents are executed, filled in and controlled to a high standard.
    • Making sure that reviewer comments are promptly and effectively incorporated and that the performance of execution is continuously improved over the course of the project.
    • Communicating and leading compliance with all SPL validation master plans and CQ/project procedures.
    • Managing change control for their area to achieve the objectives
  • Safety Champion for their area including:
    • Leading team in the preparation of effective risk assessments and method statements.
    • Ensuring safe handover of systems with all LOTO, communication and training to make a safe and effective handover.
    • Making sure all tests are well planned and supervised by appropriately trained, inducted and technically competent staff.
    • Leading team in understanding and following all SPL procedures and policies.
    • Leading reporting and investigation into any safety incidents with Management and SPL Safety group.
  • Transition to operations Champion for their area including:
    • Facilitating operator and technician training for all equipment.
    • Making sure all manuals, spare parts and PM information is transmitted to operations group.
    • Effective use of the commissioning and qualification phase to integrate operators and technicians into the team to make sure that operations staff become familiar with the equipment.
    • Organising and facilitating system training prior to handover.
    • System handover.

Key Performance Indicators

  • Strong knowledge and experience of Process Commissioning and Qualification
  • Management: Compliance with schedule at a system and area level with the planned resource levels
  • Feedback from customer (i.e. Quality, HSE, operations)
  • Safety: No lost time accident
  • Quality: well executed testing with minimum rework and re-execution.
  • Quality: all deviations resolved to Client satisfaction and handover completed for all systems.

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.

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