Cqv Engineer
Toronto, ON, Canada
Job Description
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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.
- Verification of installation in compliance with design and Client requirements.
- 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.
- 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.
- 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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Job Detail
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Job IdJD2308936
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationToronto, ON, Canada
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EducationNot mentioned