LL01-241118 Commissioning Authority (CxA) - Validation & Engineering Group

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Commissioning Authority (CxA)

Qualifications:

• Bachelor's Degree in Science or Engineering.
• Minimum of 8 years of experience in direct pharmaceutical, medical device or biotechnology industries.
• Must be proficient using MS Windows and Microsoft Office applications.
• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
• Available to work extended hours, possibility of weekends and holidays.

Responsibilities:

1. Develop the Owner’s User Requirements Specification and review the Construction Document documentation for clarity and completeness.
2. Prepare a draft set of equipment and system inspection documents to be used by the CxA for verification purposes during the construction phase of this project. These will include procedures for pre-functional testing (installation and operational verification) of commissioned systems prior to functional testing.
3. Prepare a set of equipment and system inspection documents to be used by the contractors for verification purpose during the construction phase of this project. These will include procedures for: Pre-Functional testing (PFC) of commissioned systems prior to functional testing.
4. PFCs will be created and executed by the CxA.
5. Functional Checklists (FC), which will be created and executed by the CxA with cooperation and involvement of all applicable parties during execution.
6. Review contractor’s submittals to ensure ongoing compliance with the User Requirement Specifications, Design and Cx requirements.
7. Develop a strategy with the owner and contractor to release chillers into operations on a phased approach. Currently there are two chillers in operations. Project will install three. We will need to commission one chiller at a time so that no disruptions to manufacturing is experienced.
8. Execution and oversight of the commissioning activities
9. Conduct commissioning meetings, as needed, with the commissioning team members to discuss commissioning scope, plan, and schedule.
10. Coordinate the commissioning work and provide input to define the estimated durations or milestones of commissioning activities that are being incorporated into the master schedule throughout construction.
11. Confirm that data or cut sheets and O&M material is submitted to the project team by the contractor in a timely manner. This material will be needed to assist in finalizing start-up and testing procedures.
12. Coordinate with the contractor to witness and verify startup of the chillers by manufacturer’s reps or specialist contractors.
13. Perform site inspection during rough-in of systems and equipment for installation verification of commissioned equipment and testing arrangements.
14. Review and approve TAB execution plan prepared by the contractor.
15. Maintain & distribute a commissioning observation log of any items or potential issues found or discrepancies. Provide the log and test results to the owner and CM with recommended actions.
16. Attend on-site meetings, as needed, during the construction phase for review of progress, coordination, and issues resolution.
17. Review duct pressure, pipe pressure tests and flushing procedure tests not witnessed, sufficient to be confident that proper test pressures, velocity measurements, clean & dirty samples and chemical cleaning procedures were followed.
18. Review other testing documents, such as, electrical, fire alarm checkout, BAS point-by-point and calibration of controls.
19. Witness equipment start-up.
20. Receive and collate Pre-Functional Checklists (PFC) with inspection sign-offs that the systems are complete and ready for functional testing.
21. Review the preliminary Test, Adjust and Balance (TAB) report of the hydronic systems.
22. Direct and witness functional performance testing of the chillers to demonstrate that the equipment and systems are operating according to the design intent and contract documents. Functional performance testing shall include operating the system and components through each of the written sequences of operation.
23. Check the system graphics to verify all graphic pages are developed and display the data in a format that is easily understood and useful to the operations department. Check the DDC points mapped to the graphics to confirm they are correct and units and system descriptors are displayed correctly.
24. Maintain a commissioning observation issues log of any items found. Provide the log and test results to the owner, GC, and subcontractors with recommended actions via email or direct distribution as owner indicates.
25. Coordinate re-testing as necessary. One re-test will be provided as part of normal checkout.
26. Notify the owner, owner’s rep, design professional and contractor of unacceptable equipment operation that fails to perform to the requirements of the contract documents because of manufacturing or installation defects which do not allow it to meet the submitted performance specification. Request an explanation of the problem and proposed solution from the contractor; and then review the proposed solutions.
27. Review O&M documentation for commissioning information completeness.
28. Experience on the following systems: Cooling Towers, Chillers. Fire Alarm, Refrigerant Monitoring System, Normal Power, Variable Frequency Drives.