CQV Engineer

CQV Engineer

Indianapolis, IN, United States

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 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.