First 100 Days of a Capital Project

Today at the ISPE Annual Meeting, some of our clients and members of our OPM Team will be presenting “First 100 Days of a Capital Project.” For years, owners, contractors, and engineers have struggled to find a concise way to know that they have the bases covered. Many times, projects are going along smoothly until someone realizes that “we forgot to handle this,” and the project slips, or at the very least is under duress. The output of this presentation is to deliver a checklist document that helps project teams, owners, and contracting entities know what steps should be taken to ensure that their project will be a success. This checklist details what needs to be addressed, when to address them, and what steps should be taken to create the greatest opportunity for success. Stop in if you have a capital project coming down the pipeline in the next few years… you will be glad you did.

Our OPM team ranges from 20 to 35 years of experience in assisting owners with the development of clean, compliant facilities and processes for companies around the globe. We have a proven ability to develop the design concept, the construction plan/components, and procurement strategy; along with a deep understanding of financial analytics required to make projects a reality. Many of our OPM team members have previously sat in the owner/end-user chair and now are in a position to assist other firms, like yourself.

We are able to deliver resources with extensive experience in a very short timeframe. Forget about the hiring process; we have already done that for you. Our OPM team members will look and act as if they are your employees, watching out for your best interest.  

From scheduling, conducting team meetings, job site owner’s meetings, minutes, estimates, third-party inspections, constructability to design reviews, we have the experienced personnel that can raise the bar for your firm on a short-term basis.

Our unique combination of technical knowledge for designing, building, and qualifying manufacturing facilities, combined with the technical process knowledge of today’s leading manufacturing facilities and equipment, allows us to assist clients in every aspect of their capital and process improvement programs.

Our OPM team has worked extensively with grassroots sites, sterile fill suites, CMO’s, big pharma companies, and startups. We have supervised and directed renovations of existing facilities, onsite operations, clean compliant manufacturing, and containment. Our OPM staff has experience with working in a team environment and possess strong leadership capabilities. Each member has a long history of successful projects, which is attributed to their depth of knowledge of personnel, products, and industry subcontractors/consultants.

Our OPM team is experienced in flow diagrams for all aspects of biotech and pharmaceutical process systems, utilities, and facilities. We regularly align facility and process proforma details for owner board presentations and help estimate the costs related to building, from facilities to components. Our OPM staff pay particular attention to spatial alignment, room for maintenance access, future expansion, and ergonomic layouts. These are critical considerations when looking at a GPM/manufacturing facility/process. We can estimate the cost of both engineering and construction of facilities, process utilities, process equipment, and full-scale operations.

Below are some of our OPM team’s current success stories:

• A large Medical Device manufacturer needed assistance with onsite OPM services due to their own team’s inexperience and workload. CAI developed a 5- to 7-year capital plan, budget for each phase, concept drawings, and a schedule of timelines that detailed not only physical modifications, but also the process systems and revenue associated with each change on a year-by-year basis. Management approved the plan and are currently in the process of executing it.

• A sterile fill operation in the Northeast contacted CAI to assist as OPM to avoid FDA compliance issues. CAI managed the overall design and construction modification of the sterile fill suite renovation as well as handled the process and facility C&Q. This fast track project was timed to allow for plant shutdown and was re-started 12 weeks later to start the qualification process. The facility has been reviewed by FDA and is now starting a new phase of renovations.

• A medical device manufacturer needed experienced OPM services to supplement their own in-house team to formulate an expansion. The client did not have qualified or experienced individuals on staff that could handle this work without affecting current projects. CAI acted on the owner’s behalf and led the project team to receive funding approval for the concept and renovation strategy.

We have the technical resources to fit your needs at CAI. For project management, program management, or more… you can count on CAI’s OPM to deliver resources that will meet your internal stakeholder’s expectations.