Ess - Engineered Systems & Services

ABOUT US

Engineered Systems & Services, Inc. (ess) is comprised of very specialized, licensed professional engineers dedicated to the success of our projects, our vendors, but above all, our clients in the pharmaceutical, biotech and semiconductor industries.

From concept to full design and construct, ess is the true design and/or build engineering company for you. Deeply rooted in the mechanical, process, and manufacturing side of industry, ess engineers specialize in working with clients one on one, striving to find that special layout or design that meets their specific user requirements and, at the same time, conforms to FDA guidelines and cGMP compliance.

Ess also offers full construction services including the creation of project schedules, work packages, scopes of work and comprehensive bids, as well as pre-qualifying and managing all contractors and their work. Commissioning teams made up of industry professionals are responsible for the execution of each project. Valuable time and money are saved by utilizing professionals to commission and startup the final product.

Finally, ess offers custom system design that includes product-specific, skid mounted systems to perform functions as needed. These include water filtration systems, water purification and distribution systems, waste water pH adjustment systems, and water for injection systems.

No projects are too small or complex. From concept to full design and construct, ess is the here for you.

Concept Design / Basis of Design / Final Design Qualification

The Concept Design is the first step in establishing the scope of work to be completed. It includes the User Requirements, General Facility Layout, and Engineering Code Review. The Concept/BOD equates to approximately 5-10% of the design costs and should never be overlooked before going forward with Capitol Appropriation Request. The Concept/BOD includes key information that is used to establish the preliminary overall cost of a project.

Project Management and Control

Once a project is approved, the Detail Design and Detail Project Schedule begins. This includes not only Process Equipment Sourcing but also Project Scheduling, Construction Considerations, Equipment Startup/Commissioning, as well as IOQ and PQ Validation. Project Management and Control is key during the remainder of the project as the team must now not only finish on time but must complete within budget constraints.

Federal and FDA Approval

Quality Personnel and Engineering will be required to create an FDA Review Package to submit to the Federal Government for approval prior to being allowed to manufacture products. This Review Package should be developed during the Detailed Design Phase such that it can be submitted at or near the end of the qualification phase.

Detailed Design and Qualification

Detailed Design and Qualification consists of a series of client interviews and team meetings that occur throughout the Detailed Design Phase. Each review will include drawing and specification review and client approval each step of the way. At completion of this Detailed Design, plans should be at or around 50% complete and the design should be relatively locked in order to prepare for the next phase, Permit Set Documentation.

Permit Set Documentation

Permit Set Documentation is done at 60-75% Detail Design completion stage and is used to communicate to the Local Code Authorities and others the plans for the project and what life safety issues are being addressed. Review of this package by the local authorities can take up to 6-8 weeks to complete, during which Detailed Work Packages are developed and Contractor Qualification begins.

Work Package Development and Contractor Qualification

Work Package Creation per Construction Discipline and Bid Package development occurs during Permit Set Review. Potential Contractor Selection is also performed during this phase. Only qualified contractors are selected to perform work assigned. Bid packages including Scheduled Milestone Completion dates are sent out to a minimum of (3) qualified contractors from each discipline. Return bids are compared to the original budget and contracts are awarded.

Startup and Commissioning

Once the physical construction is well underway and equipment becomes ready for startup and commissioning, a Commissioning Team is dedicated to executing that work alongside the Validation Team to ensure that process meets or exceeds the documentation and testing required by Validation Phase. It is important that systems are tested thoroughly and that they meet all aspects of the design intent. Any errors or omissions identified must be addressed before we begin the Validation Phase.

Validation

This is the final testing and verification that the facility performs to the original Basis of Design and Design Qualification. It is very important that this phase is executed with little or no deviations from the original Design Qualification. Any deviation will have to be officially documented and accepted by the Quality Team before they release the facility to final FDA Review and subsequent commercial manufacturing.