LL02-112224 Commissioning Specialist for Utilities Project - 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:

• Chiller Upgrade Project Commissioning Specialist

Qualifications:

• Bachelor's Degree in Science or Engineering.
• Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.
• Experience in direct process / manufacturing areas.
• 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:

Oversee and coordinate the traditionally separate functions of operational review, equipment startup, system performance verification, testing & balancing verification, control system program testing & calibration, construction & system handover documentation, and facilities operations training.

• Skills and experience requirements:

  • Develop the Owner’s URS and review the Construction Document documentation for clarity and completeness

  • 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. Commission one chiller at a time is expected so that no disruptions to manufacturing is experienced.

  • Review submittals so that background information can be obtained to aid in development of pre-functional and functional performance test procedures.

  • Inspect and verify that equipment and systems have been installed in accordance with the contract documents and manufacturer's written installation instructions.

  • Compile test result documents for systems to be commissioned.

  • Inspect and verify that equipment has been installed and placed into operation with manufacturer's recommendations, oversight and approval.

  • Receive and collate pre-functional checklists with inspection sign-offs that the systems are complete and ready for functional testing.

  • Review the preliminary and final Test, Adjust and Balance (TAB) report of the hydronic systems.

  • 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.

  • 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 points mapped to the graphics to confirm they are correct and units and system descriptors are displayed correctly.

  • Evaluate the results of operational and functional tests for the chiller system per acceptance criteria as defined in the contract documents.

  • Test the interrelationship of systems and equipment to verify performance and sequence of operation.

  • Review contractor final record drawings, schematics, one-line diagrams, etc.

  • Review O&M manuals.

  • 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.

  • Review contractor training of the owner’s personnel in the proper operation of equipment and systems. Evaluate training program and make recommendations to the owner for approval or retraining requirements.

  • Witness equipment start-up.

  • Document warranty start and end dates.

  • Identify, document, and report, for tracking and correction, all deficiencies of the work versus contract documents and performance requirements as it pertains to system commissioning.

  • Make a recommendation to the owner as to whether the systems should be accepted based on the results of the tests compared to the contract documents.