Job Summary

PDP is expanding rapidly in the United States - With opportunities both East & West Coast we are actively hiring CQV & Project Engineers at both different levels and discretions. We are currently interviewing for the following roles:

• Senior CQV Engineers
• CQV Engineers
• Project Engineers
• Validation Engineers

As part of the CQV Team reporting to the CQ Manager main responsibilities and tasks of the incumbent includes but are not limited to:

Main responsibilities

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

• FATs: Review of FAT documentation and potential attendance & support of execution at equipment FATs
• Document preparation: preparation of C&Q documents / Commissioning Test Scripts (CTSs); coordinating review and approval as required.
• 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.
• Support and coordination with 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.
• Digital CQV execution: strong knowledge of paperless CQV systems and executing in these platforms
• 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 Process engineering and/or Commissioning and Qualification.
• Languages: English - fluent in speaking and writing.
• Experience in Digital CQV execution systems / paperless CQV execution
• Broad knowledge of engineering disciplines, commissioning, compliance, qualification and quality aspects of biopharma or pharmaceutical manufacturing.

Lists Deviations Indicators Support Test Scripts Valves Performance Client Requirements Handover Key Performance Indicators Fashion Spare Parts Turnover Drawing Manuals Preventive Maintenance Calibration Utilities Investigation Checks Components Commissioning Inspection Contractors Manufacturing Availability Troubleshooting Writing C Construction Materials Pressure Education Documentation Testing Preparation Engineering Maintenance Design Communication Science English Training Management