CQV Engineer

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.