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Pharma/Biologics - Commissioning /O&M

Sector/Industry: Bio-Pharmaceutical 

Location: Dunkirk, NY

Project Duration: September 2019 – March 2020

Service Offered: Commissioning Support / Operations & Maintenance

Project Description: 

This project saw the LotusWorks team working with a global biopharmaceutical company on a new 409,000 square foot cGMP Fill/Finish Manufacturing Facility in Dunkirk, NY. The client is a pharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer. 

LotusWorks was brought in at the beginning of start-up and acted as a liaison between the owner’s rep, commissioning agent, and construction management team to help ensure a smooth commissioning process. LotusWorks also provided the client with 24/7 Operations and Maintenance support once the building’s equipment was started up. The team members that were brought in were able to adjust and succeed without having much time to learn the building systems. LotusWorks excels at being thrown into different situations and being able to adapt and come up with ideas and procedures to help guide the client and CM to a successful turn over.

Project Services:

Commissioning Support

  • Coordinated the overall commissioning effort with project subcontractors, construction managers, and client’s representation.
  • Verified documentation and submittals for scoped systems on doc control database to enable a smooth transition to the CQV process.
  • Followed a strict start-up schedule to meet deadlines and enable equipment turn-over in a timely and efficient manner.
  • Performed pre-functional testing and design verifications on wet & dry mechanical systems, process & waste systems, and electrical systems.
  • Tracked constraints & punch list items against the project and held weekly commissioning meetings with the sub-contractors.
  • Scheduled, coordinated, and recorded all training sessions for the client. 
  • Collected and documented closeout documentation for the client’s ETOP. (As-Builts, O&Ms, Training, Spare Parts)

Operations and Maintenance

  • Provided client with 3 full-time operators and 1 full-time chief stationary engineer to provide building support and run equipment 24/7.
  • Operators were essential in training the client’s personnel that were brought on for turnover.
  • Daily walkdowns and upkeep of equipment tracker were essential in keeping equipment operating without issue.
  • Helped identify field issues and helped come up with solutions to said issues.
  • Performed daily and weekly water sampling and testing to ensure system water qualities.
  • Performed boiler blowdowns and maintenance on an as needed basis.
  • Assisted with start-up and offered expertise when first running equipment.
  • Provided equipment and controls troubleshooting and worked closely with commissioning agent during functional testing.



  • Successfully supported the start-up and commissioning of the following mechanical, electrical, and process systems:
    • Boiler/Feedwater Systems
    • Plant Steam/Condensate Distribution
    • Chilled Water Plant and Cooling Towers
    • Chilled Water Distribution
    • Compressed Air Equipment
    • WFI ad Clean Steam Equipment
    • Hot Water Distribution
    • Humidification Steam
    • Air Handling Units
    • Terminal Air Handling Equipment
    • Building Automation Systems- Qualified and Non-Qualified
    • Primary Switchgear and Secondary Switch Gear
    • Electrical Distribution Systems and Equipment
    • Diesel Gen-Sets and UPS Systems
  • LotusWorks brought much-needed experience to the team with seasoned personnel, resulting in improved knowledge and stability throughout the project.
  • LotusWorks personnel were key in supporting work outside normal hours allowing work to continue which meant the momentum of each day and week carried into nightshift and weekend shifts
    • For Example, a valve needed to be replaced on one of the two working boilers and in order to coordinate the vendor on-site to do the repair, The night shift would be responsible for turning the boiler off, cooling it down, and then draining. This saved day shift from having to do this during working hours.
  • LotusWorks plant personnel have a strong understanding of their responsibilities and safe work practices and have the knowledge and practical abilities necessary to operate the plant safely and reliably
  • LotusWorks was able to help identify scope gaps throughout the project and helped work with the project managers to come up with solutions.
  • LotusWorks helped to identify, track, and closeout critical and non-critical punch list items throughout the construction and commissioning process.
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