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Bio-Pharmaceutical-Staff Augmentation & Commissioning

Sector/Industry:Pharmaceutical/ Bio-Technology
Project Duration: May 2018 to Present
Service Offered:Staff Augmentation and Operations & Maintenance

Project Description:
This project saw the LotusWorks team working with a multinational pharmaceutical client, one of the world’s largest manufacturers of injectable drugs and contract manufacturing, on their fill and finish facility in Kansas, USA.

LotusWorks started on site at the beginning of 2018 offering engineering support for the plant facility and utilities departments through Staff Augmentation, Operations & Maintenance, engineering and project management, MRO (managing stores and store vendors). The client manufacturing processes are subject to rigorous control to assure the quality of processes and products and deliver each batch, safely and effectively. The LotusWorks team on site play a pivotal role, under aggressive time constraints, in ensuring regulatory standards are adhered to, which in turn eliminates any site downtime.

Project Services:

  • Create and manage a facilities helpdesk to manage service requests, using a ticketed, triage system with a formal means of recording requests and tracking progress
  • Project Managing existing and new projects and establishing and aligning project goals, budget and schedule, while coordinating work with internal departments and external vendors
  • Performing reviews of site-wide O&M programs such as elastomer replacement and bringing existing programs up to date with best-in-class processes and technologies 
  • Reviewing Shutdown plans and optimizing the maintenance activities to the time available in the upcoming shutdown 
  • Supporting on-going investigations with SME insights and knowledge and taking follow-up actions driven from investigations and driving them to completion
  • Ensuring designs are adequate and compliant with Global Engineering Specifications as well as robust/reliable
  • Mechanical Engineering:
    - Performing reviews of existing 3rd party support activities and creating more inclusive, managed service-based contracts for activities such as Chemical Treatment programs
    - Perform review and drive corrective actions arising from Corrective Action Plans
    - Working with the MRO team to build out a more complete Spare Parts inventory
    - Walk-down and mark up of Mechanical systems (non-validated) where record drawings have been found to be inaccurate through lack of integrated update process
  • Life Safety Engineering: 
    - Analyze and debug Life Safety system to eliminate persistent Fault condition
    - Develop a Maintenance Program and issue a Request for Proposal for an Annual Maintenance Contract
    - Reverse Engineer a cause & effect matrix from the Life Safety System program
    - Develop and implement a Permit to Work system for the Fire Alarm
    - Liaise with new construction projects to validate the Fire Alarm requirements and develop scope document for same
    - Develop a set of acceptance criterion for new fire alarm installations
  • Electrical Engineering:
    - Analyze existing site electrical infrastructure for single points of failure and other reliability concerns
    - Develop a Site Electrical Infrastructure master plan to ensure adequate capacity and redundancy for future growth
    - Develop Master Scope of Work and tender documentation for the upcoming Electrical Maintenance shutdown program
    - Develop designs for centralized Back-Up generation system

             
 

Outcomes:

  • The Facilities Helpdesk improves the service requests process and prioritises work tasks by urgency, offering the client a streamlined system that is fully documented and can be used for subsequent analysis
  • The client was supported with engineering expertise which enabled a smooth handover from construction to manufacturing and experienced reduced downtime and increased productivity
  • The LotusWorks team identified and corrected costly performance deficiencies in the facility resulting in cost savings and increased equipment lifecycle
  • 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
  • Ramp-up and wind down suitability allows the client to respond quickly to industry changes /demand cycles, while saving time on administration and payroll activities
  • Critical specialized/niche knowledge infused into the client’s organisation as required
  • LotusWorks contract staff have a broad-based expertise and an ever-growing technical knowledge, due to their exposure to different industries, roles, technical environments and different user and system issues
  • LotusWorks identify unnecessary and unproductive maintenance work and alter the reactive, preventative, predictive and proactive maintenance plan accordingly to create significant cost reductions and increased efficiencies within your facility
  • MRO stores are able to support all aspects of the site while focusing on criticality of assets, creating a proactive instead of reactive culture
  • Inflated inventory levels are controlled, and unnecessary spending eliminated
The scope of work on this client site has continued to increase and the LotusWorks team on site today play an integral part in the engineering support for the plant facilities and utilities departments. 
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