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CQV Engineer

CQV Engineer

Project Delivery PartnersRaleigh, NC, US
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Job Description

Job Description

PDP is a CQV Project Partner in Raleigh, NC. We are actively interviewing CQV Engineers who have strong knowle dge and experience of Upstream / Downstream / Clean / Black Utilities / Support Services Commissioning and Qualification.

Main responsibilities

  • FATs : Attendance & support of execution at equipment FATs
  • Walk down of mechanically complete systems including :

Verification of installation in compliance with design and Client requirements.

Identification of any technical issues as well as ergonomic and operational defects in the installation.

  • Clear communication of defects and punchlist items to the General Contractor and subcontractor and the later verification and approval of rectification of defects.
  • Communication with Client Subject Matter experts on the redline drawing, and technical issues arising from the walkdown.
  • Verification of the as-build design documents.

    • Marking updates to the drawing during walkdown.

  • Raising and closeout of Change control documentation to deal with any agreed changes to the design, in conjunction with the Client Subject Matter experts.
  • Witnessing of critical construction testing where relevant.
  • Review of turnover binders from the various relevant contractors, including :

    • Review of all construction test packs and verification of all construction quality documents including pressure test, weld inspection, material certification, passivation, loop checks etc.

  • Verification of all operation and maintenance turnover, including manuals, spare parts lists, training documents etc.
  • Execution of Design Qualification including :

    • Verification of the Client design in the relevant vendor design and turnover documents.

  • Raising of issues as they arise to the Client Subject Matter experts.
  • Raising of any change controls and deviations and discussing same with subject matter experts and Client reviewers.
  • Execution of Installation Verification including :

    • Verification of documentation for critical elements of the system including Execution of Installation Verification including Drawings, Manuals, Preventive Maintenance, Spare / Change Parts and Lubricants.

  • Verification (for critical components) of tagging, size / range, material, installation and design compliance of all components including Instruments, Equipment, Piping, Valves / traps and other components.
  • Verification of spare / change parts and preventative maintenance set-up.
  • Verification of drawings and other design as-builds.
  • Verification of installation / construction testing and certification including pressure testing, cleaning / passivation, calibration, loop checks, weld and material inspection and any other relevant construction quality documents.
  • These activities, especially for direct impact systems, must be leveragable.
  • Raising of issues as they arise to the Client Subject Matter experts.
  • Raising of any change controls and deviations and discussing same with subject matter experts and Client reviewers.
  • Execution of Operational Verification including :

    • Verification of the operation of the equipment including all automated and manual functions.

  • These activities, especially for direct impact systems, must be leveragable.
  • Raising of issues as they arise to the Client Subject Matter experts.
  • Raising of any change controls and deviations and discussing same with subject matter experts and Client reviewers.
  • Compliance with schedule including

    • Completion of tasks in a timely fashion on or before scheduled date.

  • Reporting progress for their systems, with

    • Accurate status and % completion being reported on all tasks.

  • Schedule risks clearly identified as they arise.
  • Identification and early resolution of any and all schedule risks including :

    • Verifying all test pre-requisites are in place including personnel, materials, utilities, equipment and instruments.

  • Verifying that all vendor and trade support is well planned and managed.
  • Verifying document availability and timely signoff of all documents.
  • Technical stewardship including :

    • Troubleshooting and resolving all issues.

  • Discussing and resolving with manager and subject matter experts all deviations, changes, design issues and test failures.
  • Safety Compliance including :

    • Preparation / review 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 executed safely.
  • Understanding and following all Client procedures and policies.
  • Reporting and investigation into any safety incidents with Management and Client Safety group.

    • Key Performance Indicators

  • Strong knowledge and experience of 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

  • Education (minimum / desirable) : Minimum BS or equivalent in Engineering or Science - preferably in Chemical, Mechanical or Pharmaceutical Engineering.
  • Experience in Commissioning and Qualification.
  • Languages : English - fluent in speaking and writing.
  • Experience : Minimum 3 yrs.
  • Broad knowledge of engineering disciplines, commissioning, compliance, qualification and quality aspects of biopharma or pharmaceutical manufacturing.
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