Raleigh
Job Description PDP is a CQV Project Partner in Raleigh, NC. We are actively interviewing CQV Engineers who have strong knowledge and experience of Upstream / Downstream / Clean /Black Utilities / Support Services Commissioning and Qualification. 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., • 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., • 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.