: 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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