CQV Engineer

Project Delivery Partners

Indianapolis, IN

Job Description:

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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Vacancy posted 5 days ago

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