CQV Engineer at Project Delivery Partners

Indianapolis, Indiana, United States -

Full Time

Start Date

Immediate

Expiry Date

26 Sep, 26

Salary

0.0

Posted On

28 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Commissioning and Qualification, FAT Execution, Design Qualification, Installation Verification, Operational Verification, Change Control, Technical Troubleshooting, Risk Assessment, LOTO, Biopharma Manufacturing, Construction Quality Documentation, Redline Drawing

Industry

Pharmaceutical Manufacturing

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.

Responsibilities

The CQV Engineer is responsible for executing Factory Acceptance Tests, Design Qualification, Installation Verification, and Operational Verification. They ensure systems comply with design requirements and manage the closeout of punchlist items and change controls.